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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 Problems Urinary Incontinence (4572); Insufficient Information (4580)
Event Date 02/08/2021
Event Type  Injury  
Event Description
It was reported that the patient underwent a surgical procedure to revise this male sling due to unspecified reasons.The sling remains implanted and active and a new artificial urinary sphincter (aus) was implanted.
 
Manufacturer Narrative
Correction: the male sling is not a bsc product.
 
Event Description
It was reported that the patient underwent a surgical procedure to revise this male sling due to stress incontinence from the non-bsc device.The sling remains implanted and active and a new artificial urinary sphincter (aus) was implanted.
 
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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 Key11349607
MDR Text Key232583061
Report Number2183959-2021-00567
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,o
Type of Report Initial,Followup
Report Date 02/26/2021
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 02/08/2021
Initial Date FDA Received02/19/2021
Supplement Dates Manufacturer Received02/23/2021
Supplement Dates FDA Received02/26/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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