The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.The device has been received at coloplast; however the evaluation is not yet complete.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
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According to the available information, there was an unknown device failure, unknown drainage of reservoir fluid.Pump wouldn't work.No obvious damage or defect detected upon explant.Device explanted, replaced with non-coloplast product.
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