Model Number 72404310 |
Device Problems
Break (1069); Collapse (1099); Fluid/Blood Leak (1250); Inflation Problem (1310)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2019 |
Event Type
Injury
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Event Description
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It was reported that the inflatable penile prosthesis (ipp) pump was explanted due to "fluid loss with a connector crack." a new ipp pump was implanted.It was further reported that the pump remained dimpled and would not inflate properly due to the fluid loss.The fluid loss was identified by the physician after testing during surgery.The device complications began two weeks prior to surgery.The patient was doing well following the surgery.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.
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Manufacturer Narrative
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Device evaluation: the complaint component was returned and analyzed, and the reported allegation of inflation issues was confirmed via product analysis.Based on the results of this investigation, no escalation is necessary.
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Event Description
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It was reported that the inflatable penile prosthesis (ipp) pump was explanted due to "fluid loss with a connector crack." a new ipp pump was implanted.It was further reported that the pump remained dimpled and would not inflate properly due to the fluid loss.The fluid loss was identified by the physician after testing during surgery.The device complications began two weeks prior to surgery.The patient was doing well following the surgery.Product was explanted and expected to be returned.A supplemental report will be filed after product has been returned and product analysis has been completed.
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Search Alerts/Recalls
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