Model Number QS89181000 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/24/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number: 0936689.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, tubing leak.The device was removed/replaced.Additional information received indicated no leak origin was found and that it may have been minuscule.
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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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Event Description
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This follow-up mdr is created to document the additional event information received for record #603613.According to the available information the inflatable penile prosthesis was implanted on (b)(6) 2007 and removed/replaced on (b)(6) 2020 due to a tubing leak.Additional information received from the regional sales director indicated: ¿none was found¿ (regarding leak origin).It may have been miniscule.¿ 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 revealed no trends for this lot.Review of nonconforming reports revealed no nonconformances for this lot.No capas are associated with this lot.
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Search Alerts/Recalls
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