Model Number UNK-P-SLING-MENS |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Urinary Incontinence (4572)
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Event Date 08/31/2022 |
Event Type
Injury
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Event Description
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It was reported that the patient experienced increased incontinence over time, after the sling was implanted.An artificial urinary sphincter (aus) was implanted.There were no device issues with the sling.There were no patient complications.
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Event Description
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It was reported that the patient experienced increased urinary incontinence over time, after the sling was implanted.An artificial urinary sphincter (aus) was implanted.There were no device issues with the sling.There were no patient complications.
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Manufacturer Narrative
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There was no device available for analysis and there was no report of a device performance allegation during treatment.The reported patient symptoms are known risk associated with implants of these device as indicated in the instructions for use (ifu).The device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.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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