Model Number UNK-P-SLING-MENS_ADVANCE |
Device Problem
Insufficient Information (3190)
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Patient Problems
Urinary Incontinence (4572); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/11/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient previously had a male sling advance implant and underwent a surgical procedure in which an artificial urinary sphincter (aus) was implanted.The reason of the surgery was not specified.No further information was provided.
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Manufacturer Narrative
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Investigation summary: based on the information available, the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the sling instructions for use (ifu).The sling ifu lists altered therapeutic response as a potential adverse event(s) associated with implant of this device.Investigation conclusion: based on the information available, a conclusion code of cause not established was assigned to this investigation.
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Event Description
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It was reported that the patient previously had a male sling advance implant and underwent a surgical procedure in which an artificial urinary sphincter (aus) was implanted.The reason of the surgery was not specified.No further information was provided.
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Manufacturer Narrative
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Information updated: describe event or problem, patient codes, evaluation conclusion codes and additional mfr narrative investigation summary: based on the information available, the cause that contributed to the reported event cannot be established as the product is not available for analysis.Device history record review: a dhr and ship history cannot be performed as the serial/lot number for this component was not available.Device technical analysis: the device is not available for analysis; therefore, no physical or visual analysis of the product could be performed.The reported device performance allegation cannot be confirmed.Without a returned product available for analysis and based on this investigation a clear probable cause for the event cannot be established.Labeling review: a review of the device instructions for use (ifu) was completed and did not reveal any evidence of device misuse, off label use, or failure to follow instructions.There is no objective evidence that the user did not properly handle or use the device according to the sling instructions for use (ifu).The sling ifu lists incontinence as a potential adverse event(s) associated with implant of this device.Investigation conclusion: 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 previously had a male sling advance implant and underwent a surgical procedure in which an artificial urinary sphincter (aus) was implanted because the patient was experiencing incontinence.No further information was provided.
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Search Alerts/Recalls
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