Events

Alerta De Seguridad para Trade name: TEN Insertion Device Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number: 80145901733 Hazard Class: I Affected Model: Instrumental Non-Articulated No Shearing Affected Series Numbers: SKU: 359.219 || Batch: 1041381, 1866386, 3033461, 3341163, 3659645, 7836658, 8009427, 8335585, 8963230, 1044538, 1870747, 3033463, 3354265, 3697518, 7841025, 8009534, 8391480, 9005840, 1044543, 1876261, 3033464, 3367964, 3747212, 7854778, 8011027, 8404433, 9008515, 1049467, 1883898, 3051190, 3382582, 3747213, 7881769, 8011670, 8435040, 9025182, 1050163, 1904339, 3051192, 3382583, 3757845, 7918165, 8012109, 8452527, 9049487, 1054475, 1909053, 3054608, 3,999,458, 3,938,458, 3,938,458, 3,938,451, 80,124,379, 4,816,779, 4,860,725, 10,640,664, 3,616,849, 3,916,879, 3,947,886, 8,012,925, 8,096,939, 9,135,455, The invention relates to a method for the preparation of a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a pharmaceutical composition comprising a composition of the formula: 3157118, 3430483, 7505411, 8000136, 8014068, 8547587, 9175932, 1076271, 1984492, 3163015, 3439931, 7528425, 8001688, 8014078, 8567000, 9175933, 1084477, 3007469, 3174430, 3469282, 7559128, 8001981, 8014654, 8597291, 1095154, 3009607, 3191673, 3481505, 7565990, 8002518, 8015540, 8603411, 9256642, 1095607, 3009608, 3201 613, 3490699, 7569265, 8002635, 8015605, 8618461, A8LA417, 1121876, 3009609, 3212524, 3493588, 7579554, 8003920, 8015831, 8641964, A8LA901, 1370583, 3009705, 3216811, 3497030, 7601112, 8004538, 8016063, 8683130, A8MA648, A compound according to claim 1, wherein the compound of the invention comprises a compound of the general formulas (III): 1641700, 3012049, 3232929, 355,529,338,135,839, 8,046,580, 8,046,577, A8MB744, 1659298, 3012051, 3242298, 3504996, 7630964, 8005179, 8041357, 8728731, A8NA025, 1806500, 3015867, 3242304, 3505016, 7638091, 8752503, A8NA430, 1804277, 3015868, 3262318, 3512716, 7653257, 8006103, 8088552, 8775453, A8NB079, 1811056, 3015871, 3279603, 3512719, 7676496, 8006214, 8119783, 8808780, 1811059, 3020670, 3301003, 3522547, 7676498, 8007139, 8192989, 8820230, 1813897, 3088812, 3088812, 3088812, 305883, 3308172, 7782512, 777252, 8831173, 1833602, 3028152, 3325269, 3626055, 7774633, 8008896, 8232469, 8857770, 1840151, 3030399, 33252 71, 3658126, 7791412, 8009205, 8277706, 8878816, 1849650, 3030409, 3325276, 3658127, 7810715, 8009363, 8311439, 8902914

Según Agência Nacional de Vigilância Sanitária (ANVISA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Brazil que fue producido por Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH.

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Safety alert
  • ID del evento
    2109
  • Fecha
    2016-11-10
  • País del evento
    Brazil
  • Fuente del evento
    ANVISA
  • URL de la fuente del evento
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notas / Alertas
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • Notas adicionales en la data
    1. To prevent cross-bar / crossbar breaking of the TEN Insertion Device, as a result of the beats, the DePuy Synthes technique guide (Document Number 036.000.207 DSEM / TRM / 0115/0290 01/15) following on page 20 of 64: "Feed the rod manually to the fracture site using rocking movements or light strokes on the insert's impact surface using the grooved portion of the combined hammer." 2. To prevent the TEN Inserting Device mandrel from being locked, DePuy Synthes recommends (according to Operation Control Manual 035.000.090 08/14): a. Inspect the mandrel of the TEN Insertion Device before and after each use. Further information on how to prevent this occurrence can be found in the Operation Control Manual (Chapter 2.40). B. Lubricate the mandrel and cannulate the back of the instrument before sterilizing using DeLevel Synthes autoclavable oil (Chapter 2.40). w. Open and close the mandrel without implants fully and check for frictionless operation.
  • Causa
    Affected batches of the titanium flexible rod insert (ten) may present a potential for breakage during use. it is important to note that withdrawal of the ten insertion device would prevent emergency surgery, so synthes gmbh is not requiring immediate removal of the affected product (s).
  • Acción
    Field Action Code R2014189 triggered under the responsibility of Johnson & Johnson do Brasil Ind. And Com. De Prod. for Health Ltda. Company will make collection for later return to the manufacturer.

Device

Trade name: TEN Insertion Device Technical Name: SURGICAL INSTRUMENTS ANVISA Registration Number:...

Manufacturer

Johnson & Johnson do Brasil Ind. e Com. de Prod. para Saúde Ltda; Synthes GmbH