Model Number UNK-P-IPP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Seroma (2069); Discomfort (2330)
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Event Date 09/13/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent surgical intervention to explant the inflatable penile prosthesis (ipp) due to discomfort and infection.The patient presented prior to the surgery with the discomfort and a seroma was drained.A couple weeks later, the patient was still experiencing discomfort and the physician identified the patient had developed an infection in the penis.After the explant, the infection was treated.The patient is expected to fully recover.
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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 underwent surgical intervention to explant the inflatable penile prosthesis (ipp) due to discomfort and infection.The patient presented prior to the surgery with the discomfort and a seroma was drained.A couple weeks later, the patient was still experiencing discomfort and the physician identified the patient had developed an infection in the penis.After the explant, the infection was treated.The patient is expected to fully recover.
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Search Alerts/Recalls
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