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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2020
Event Type  Injury  
Event Description
It was reported that the patient had unknown sling implanted on an unknown date.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted due to unspecified reasons.
 
Event Description
It was reported that the patient had a locally sling implanted on an unknown date.A new artificial urinary sphincter consisting of a cuff, pump, and balloon was implanted due to unspecified reasons.Additional information received indicated the sling was another local manufacturer sling.
 
Manufacturer Narrative
Upon additional information received, the device is another manufacturer's device and not a bsc device.It was determined that this does not meet the criteria for a reportable event.
 
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Brand Name
AMS SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
MDR Report Key11069753
MDR Text Key223589932
Report Number2183959-2020-06103
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Model NumberUNK-P-SLING-MENS
Device Catalogue NumberUNK-P-SLING-MENS
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received12/23/2020
Supplement Dates Manufacturer Received12/28/2020
Supplement Dates FDA Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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