Model Number UNK-P-IPP |
Device Problem
Inadequacy of Device Shape and/or Size (1583)
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Patient Problem
Insufficient Information (4580)
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Event Date 11/13/2023 |
Event Type
Injury
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Event Description
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It was reported that this inflatable penile prosthesis (ipp) was undersized to patient's anatomy, therefore it did not reach the glans.A revision surgery was performed to explant and replace the device with a larger size.No patient complications were reported.
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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.
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Event Description
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It was reported that this inflatable penile prosthesis (ipp) was undersized to patient's anatomy, therefore it did not reach the glans.A revision surgery was performed to explant and replace the device with a larger size.No patient complications were reported.
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Search Alerts/Recalls
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