Model Number 72404237 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Seroma (2069); Discomfort (2330)
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Event Date 03/30/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient with this inflatable penile prosthesis (ipp) had fluid in their scrotum; this resulted in discomfort and precluded use of the device.A full antibiotic washout was done, and the device was explanted and replaced with a new ipp.No further 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.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 had the inflatable penile prosthesis removed as fluid had filled the scrotum over the past two years resulting in the patient presenting with discomfort and inability to use the device.A full antibiotic washout was done, and a new inflatable penile prosthesis was implanted.No further patient complications were reported.
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Search Alerts/Recalls
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