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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
Event Type  Injury  
Event Description
It was reported the patient had an unknown sling implanted on an unknown date.The patient was implanted with an artificial urinary sphincter on a later date due to a periprosthetic infection.
 
Manufacturer Narrative
Change to describe event or problem.
 
Event Description
It was reported the patient had an unknown sling implanted on an unknown date.The sling did not work so the patient was successfully implanted with an artificial urinary sphincter on a later date.The patient had no further issues.
 
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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 Key11217496
MDR Text Key258331114
Report Number2183959-2021-00096
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 02/18/2021
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 12/30/2020
Initial Date FDA Received01/22/2021
Supplement Dates Manufacturer Received01/26/2021
Supplement Dates FDA Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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