Events

Retiro De Equipo (Recall) de Medtronic MiniMed(TM) Silhouette(TM)

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Inc..

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    78125
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-0108-2018
  • Fecha de inicio del evento
    2017-09-10
  • Estado del evento
    Open, Classified
  • País del evento
    United States
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158698
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Set, administration, intravascular - Product Code FPA
  • Causa
    Medtronic minimed(tm) infusion sets have the potential for over-delivery of insulin.
  • Acción
    The firm initiated its recall on 09/11/2017 by issuing a public notice, following with letters and emails. The firm also employed the use of Facebook and Twitter as well as posting on its website. The recall notice directs the customer to visit https://checklots.medtronicdiabetes.com for information on the lot numbers. Persons with additional questions may call Medtronic at 1.888.204.7616.

Device

Medtronic MiniMed(TM) Silhouette(TM)
  • Modelo / Serial
    Lot Numbers: 5179979 5182542 5185471 5187173 5188894 5189581 5191349 5192467 5178077 5189588 5181137 5181140 5184757 5184758 5186199 5186203 5188890 5191350 5193510 5186206 5179854 5179857 5179975 5181712 5182176 5182543 5183121 5185154 5185157 5186200 5186201 5186202 5187102 5187170 5188889 5188893 5190033 5190708 5190710 5191351 5192470 5192679 5194101 5168207 5189592 5175824 5176442 5179855 5179977 5181711 5181713 5182177 5182179 5182544 5183122 5183123 5184087 5185155 5185156 5187101 5187171 5187817 5188886 5188887 5188888 5188895 5189583 5189584 5189585 5189586 5190031 5190707 5190709 5192468 5192469 5192471 5192680 5192691 5192692 5193308 5194100 5178081 5185473 5186207 5187821 5189590 5191354 5178084 5183072 5185153 5187103 5187818 5187819 5187820 5188892 5193505 5178076 5189591 5175953 5181138 5185472 5187172 5191352 5192682 5186205 5181139 5186204 5189587
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide
  • Descripción del producto
    Medtronic MiniMed(TM) Silhouette(TM) (MMT-377, 377T, 378, 378T, 384, 384T, 368, 368T, 381, 381T, 382, 382T, 383, 383T)
  • Manufacturer
    Medtronic Inc.

Manufacturer

Medtronic Inc.
  • Dirección del fabricante
    Medtronic Inc., 18000 Devonshire St, Northridge CA 91325-1219
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA