The Implant Files -
International Medical Devices Database
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- International Medical Devices Database
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- Resources for patients
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- Video introduction
Historias - Patients harmed by medical devices
- Europe, a device gateway to the world
- History of the industry
- The Medtronic way
- Ruptured trust and breast implants
- Heart device raises risk questions
Retiro De Equipo (Recall) de ONE STEP URINE LH OVULATION TEST STRIP FORMAT
Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ARTRON LABORATORIES 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
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ID del evento
50676
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Clase de Riesgo del Evento
II
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Fecha de inicio del evento
2012-01-24
- 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
The product labels did not include the manufacturer's address at the time of sale. product licenses had expired but were later reinstated.
Device
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Modelo / Serial
Model Catalog: A01-03-113 (Lot serial: LH-511102); Model Catalog: A01-03-113 (Lot serial: LH-510901); Model Catalog: A01-01-130 (Lot serial: HCG-511104); Model Catalog: A01-01-130 (Lot serial: HCG-510902); Model Catalog: A01-02-113 (Lot serial: HCG-511105); Model Catalog: A01-01-113 (Lot serial: HCG-510902); Model Catalog: A01-02-130 (Lot serial: HCG-511103-UM); Model Catalog: A01-02-130 (Lot serial: HCG-510906); Model Catalog: A01-03-130 (Lot serial: LH-511103-M); Model Catalog: A01-03-130 (Lot serial: LH-510901); Model Catalog: A01-01-113 (Lot serial: HCG-511103); Model Catalog: A01-02-113 (Lot serial: HCG-510906)
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Descripción del producto
LH Strip - Ovulation Strip Test
- Manufacturer
Manufacturer
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Dirección del fabricante
BURNABY
- Empresa matriz del fabricante (2017)
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Source
HC