Model Number UNK-P-IPP |
Device Problems
Malposition of Device (2616); Migration (4003)
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Patient Problems
Pain (1994); Discomfort (2330)
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Event Date 01/10/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced pain and discomfort with this inflatable penile prosthesis (ipp) due to the pump location.The pump was too close to the testicle and migrating slightly.The pump was removed and replaced in a better location.There were no additional patient complications.
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Manufacturer Narrative
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There was no device available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported patient symptoms are a known risk associated with implant of these devices as indicated in the instructions for use.Based on the information available, a conclusion code of known inherent risk of device was assigned to this investigation.
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Event Description
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It was reported that the patient experienced pain and discomfort with this inflatable penile prosthesis (ipp) due to the pump location.The pump was too close to the testicle and migrating slightly.The pump was removed and replaced in a better location.There were no additional patient complications.
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Search Alerts/Recalls
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