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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH
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AMERICAN MEDICAL SYSTEMS (MN) AMS ADVANCE MALE SLING SYSTEM; SURGICAL MESH Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problem No Information (3190)
Event Type  Injury  
Event Description
It was reported the patient had an advance sling implanted on an unknown date.It was indicated that the advance either "eroded or was placed through the urethra at the time of surgery".The advance was removed and the urethra was repaired.It was indicated that "approximately 6 months later", on (b)(6) 2014, the patient was implanted with another incontinence device.No additional patient complications were reported in relation to this event.
 
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Brand Name
AMS ADVANCE MALE SLING SYSTEM
Type of Device
SURGICAL MESH
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer (Section G)
AMERICAN MEDICAL SYSTEMS (MN)
10700 bren road w
minnetonka MN 55343
Manufacturer Contact
sharon zurn
10700 bren road w
minnetonka, MN 55343
9529306000
MDR Report Key3911485
MDR Text Key4520847
Report Number2183959-2014-00269
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/03/2014
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/02/2014
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;
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