Model Number ESR9202400 |
Device Problems
Positioning Problem (3009); Pumping Problem (3016)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/20/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number: 3725434.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, revision occurred as the patient presented with not being able to pump.The issue was resolved intraoperatively with the pump after being exposed (capsulotomy) and the pump re-positioned.Device was not removed.
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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 #603278.According to the available information the inflatable penile prosthesis was implanted on (b)(6) 2013 and revised on (b)(6) 2020 due to a capsular formation.Additional information received from the territory manager indicated that the revision occurred as the patient presented with not being able to pump.The issue was resolved intraoperatively with the pump after being exposed (capsulotomy) and the pump re-positioned.The device was not received for evaluation as it remains implanted.As examination of the device may not conclusively confirm or disprove the report of capsular formation quality accepts the physician¿s observations as to the reason for surgical intervention.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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