Model Number ES28222400 |
Device Problem
Migration (4003)
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Patient Problem
Erosion (1750)
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Event Date 09/10/2019 |
Event Type
Injury
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Manufacturer Narrative
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The lot number was reviewed for complaint trend, nonconforming reports and capa review.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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Event Description
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According to the available information, erosion was noted.Cross-over functioning implant.Another inflatable penile prosthesis was implanted.
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Event Description
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Clarify that it was reported that during explant, cross-over was noted, the implant was functioning.Erosion was also noted.
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Manufacturer Narrative
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This follow-up was created to clarify the original event description and conclusion of the investigation.A titan touch pump, reservoir, and two cylinders were received for evaluation.As examination of the components may not conclusively confirm or disprove the report of erosion, or crossover, 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, non-conformances and capas revealed no trends for this lot.
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Search Alerts/Recalls
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