Events

Alerta De Seguridad para Other-Sonic Generic Ultrasound Transmission Gel

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Pharmaceutical Innovations.

¿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
  • Fecha
    2012-04-19
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120419.html
  • Notas / Alertas
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Field safety notice: other-sonic generic ultrasound transmission gel the food and drug administration (fda), united states, has issued a safety communication on other-sonic generic ultrasound transmission gel manufactured by pharmaceutical innovations, inc. fda alerted that health care professionals and facilities to stop using other-sonic generic ultrasound transmission gel manufactured june through december 2011 because of bacterial contamination. the contamination was found in 250 milliliter (ml) bottles and 5 liter (l) dispensing containers with lot numbers 060111, 090111 and 120111. the fda received a report from a hospital that 16 patients had developed colonization or infection with the bacteria pseudomonas aeruginosa. each of these patients was examined with transesophageal ultrasound probes using other-sonic generic ultrasound transmission gel. upon investigation, the ultrasound gel was found to be contaminated with the bacteria pseudomonas aeruginosa and klebsiella oxytoca. regarding the captioned product, the fda recommends healthcare professionals and facilities to: stop using other-sonic generic ultrasound transmission gel from lot numbers 060111 through 120111. identify patients who have been exposed to these lots of other-sonic generic ultrasound transmission gel and review the procedures they underwent and the outcomes of those procedures. for details, please refer to fda website http://www.Fda.Gov/medicaldevices/safety/alertsandnotices/ ucm299409.Htm and http://www.Fda.Gov/safety/medwatch/safetyinformation/ safetyalertsforhumanmedicalproducts/ucm300873.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Other-Sonic Generic Ultrasound Transmission Gel

Manufacturer

Pharmaceutical Innovations