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Retiro De Equipo (Recall) de DURAPREP SURGICAL SOLUTION
Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por NORTHLAND HEALTHCARE PRODUCTS LIMITED.
¿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
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ID del evento
66909
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Clase de Riesgo del Evento
II
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Fecha de inicio del evento
2015-08-25
- País del evento
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Fuente del evento
HC
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Notas / Alertas
Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada. -
Notas adicionales en la data
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Causa
During investigation into a complaint of discoloured duraprep solution 3m determined that the product solution had unintended exposure to the sterilant during package sterilization. this type of exposure would only be possible if the glass ampule holding the solution is compromised with a crack. direct exposure to the sterilant causes a color change from dark brown to yellow/clear and renders the product unfit for use given formation of byproducts with the potential for sensitization irritation and acute dermal toxicity.
Device
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Modelo / Serial
Model Catalog: 8635 (Lot serial: 2016-08DC); Model Catalog: 8630 (Lot serial: 2016-08DC); Model Catalog: 8635 (Lot serial: 2016-09EG); Model Catalog: 8630 (Lot serial: 2016-09EE); Model Catalog: 8635 (Lot serial: 2016-09EF); Model Catalog: 8630 (Lot serial: 2016-09EF); Model Catalog: 8635 (Lot serial: 2016-09EE); Model Catalog: 8630 (Lot serial: 2016-09EG)
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Descripción del producto
3M DuraPrep Surgical Solution Patient Preoperative Skin Preparation
- Manufacturer
Manufacturer
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Dirección del fabricante
WINNIPEG
- Empresa matriz del fabricante (2017)
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Source
HC