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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
Device Problems Defective Device (2588); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2019
Event Type  Injury  
Event Description
It was reported that the patient experienced an revision surgery due to an ineffective advance xp sling device.An artificial urinary sphincter(aus) device was implanted to complete the procedure.A patient outcome was not reported.
 
Manufacturer Narrative
Additional information received that the sling may have slipped from its position and was not effective enough in controlling the incontinence.A patient outcome of no complications was reported.
 
Event Description
It was reported that the patient experienced an revision surgery due to an ineffective advance xp sling device.An artificial urinary sphincter(aus) device was implanted to complete the procedure.A patient outcome was not reported.
 
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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 Key8705405
MDR Text Key148214415
Report Number2183959-2019-64169
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
PMA/PMN Number
K182169
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 06/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Date Manufacturer Received06/23/2019
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age79 YR
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