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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 720163-01
Device Problems Malposition of Device (2616); Insufficient Information (3190)
Patient Problems Incontinence (1928); No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2020
Event Type  Injury  
Event Description
It was reported that the patient underwent a revision procedure due to unspecified reasons with an unknown male sling.The sling remains implanted and a new artificial urinary sphincter (aus) was implanted.
 
Manufacturer Narrative
Additional information: b5, d4, h6.
 
Event Description
It was reported that the patient underwent a revision procedure due to unspecified reasons with an unknown male sling.The sling remains implanted and a new artificial urinary sphincter (aus) was implanted.Additional information was reported that the patient was still incontinent, the physician believes the advance xp male sling came out of it's place and the patient was still leaking the following day of the sling implant.The sling implant was in (b)(6) 2018.
 
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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
100 boston scientific way
marlborough MA 01752 1242
MDR Report Key9706620
MDR Text Key179270289
Report Number2183959-2020-00664
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 03/02/2020
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 Number720163-01
Device Catalogue Number720163-01
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/22/2020
Initial Date FDA Received02/13/2020
Supplement Dates Manufacturer Received02/26/2020
Supplement Dates FDA Received03/02/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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