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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS ADVANCE
Device Problem Insufficient Information (3190)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/09/2018
Event Type  Injury  
Event Description
It was reported that the patient had an advance sling procedure and the level of incontinence had improved following the implant.An artificial urinary sphincter (aus) device consisting of a 4.0cm cuff, 61cm prb was then implanted.
 
Event Description
It was reported that the patient had an advance sling procedure and the level of incontinence had improved following the implant.An artificial urinary sphincter (aus) device consisting of a 4.0cm cuff, 61cm prb was then implanted.
 
Manufacturer Narrative
Updated device brand name model number.Device not returned for evaluation.
 
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Brand Name
AMS ADVANCE 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 Key8169943
MDR Text Key130517641
Report Number2183959-2018-61741
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
PMA/PMN Number
K053371
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/13/2019
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 ADVANCE
Device Catalogue NumberUNK-P-SLING-MENS ADVANCE
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/30/2018
Initial Date FDA Received12/17/2018
Supplement Dates Manufacturer Received05/31/2019
Supplement Dates FDA Received06/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age76 YR
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