Model Number QS89201002 |
Device Problems
Break (1069); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 06/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number: 5714567.The lot number was reviewed for complaint trend, nonconforming report and capa.Devices met specification prior to release and no trends were noted.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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Event Description
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According to the available information, fluid loss.Visible tubing broken at cylinder tubing.The device was removed/replaced.
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Event Description
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This follow-up mdr is created to document the additional event information received for record #(b)(4).According to the available information the penile implant was implanted on 10/18/2007, removed and replaced on 06/19/2020 due to fluid loss.Information received indicated that the physician noted that a cylinder tubing break was visible.The device was not received for evaluation.Without the benefit of analyzing the device, quality cannot confirm any observations or comment on the condition of the product.If the device becomes available, or additional information is received, the complaint will be re-evaluated according to procedures.A review of the device history record confirmed the devices from this lot met all specifications prior to release.A review of the complaint history database, non-conformances and capas revealed no trends for this lot.
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Manufacturer Narrative
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Based on the available information, the reported complaint is identified in the risk management documentation and reviewed routinely with management to monitor complaint trends as part of post market surveillance.No corrective action is required at this time.
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Search Alerts/Recalls
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