Model Number UNK-P-AUS |
Device Problems
Fluid/Blood Leak (1250); Material Puncture/Hole (1504)
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Patient Problem
Urinary Incontinence (4572)
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Event Date 01/02/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision of the artificial urinary sphincter (aus) due to incontinence.Upon explant, a hole was observed in the balloon causing fluid loss.The balloon was removed and replaced.There were no patient complications.
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Event Description
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It was reported that the patient underwent a revision of the artificial urinary sphincter (aus) due to incontinence.Upon explant, a hole was observed in the balloon causing fluid loss.The balloon was removed and replaced.There were no 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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Search Alerts/Recalls
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