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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
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BOSTON SCIENTIFIC CORPORATION AMS ADVANCE XP SLING SYSTEM; MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE Back to Search Results
Model Number UNK-P-SLING-MENS_ADVANCE_XP
Device Problem Insufficient Information (3190)
Patient Problem Incontinence (1928)
Event Date 05/14/2021
Event Type  Injury  
Event Description
It was reported that a patient still had severe incontinence, 10 pads per day, following the implantation of the advanced xp sling.Therefore, an artificial urinary sphincter (aus) was implanted.It was indicated that it was too early to assess the outcome of the procedure performed.
 
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Brand Name
AMS ADVANCE XP SLING SYSTEM
Type of Device
MESH SURGICAL FOR STRESS URINARY INCONTINENCE MALE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
alyson harris
4100 hamline avenue north
building c
saint paul, MN 55112
4089353452
MDR Report Key11976292
MDR Text Key255428747
Report Number2124215-2021-16229
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeHR
PMA/PMN Number
K182169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other
Type of Report Initial
Report Date 06/10/2021
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_ADVANCE_XP
Device Catalogue NumberUNK-P-SLING-MENS_ADVANCE_XP
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/20/2021
Initial Date FDA Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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