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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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AMERICAN MEDICAL SYSTEMS, INC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Death (1802); Pain (1994); Prolapse (2475); Blood Loss (2597)
Event Date 01/25/2007
Event Type  Death  
Event Description
It was reported by the plaintiff's attorney that the plaintiff experienced vaginal sling erosion, recent difficulty emptying bladder, first degree cystocele and first degree rectocele.It was also reported that the plaintiff experienced abnormal uterine bleeding, pelvic pain, and dyspareunia.Furthermore, it was reported that the plaintiff died.No cause of death was reported.
 
Manufacturer Narrative
Lawyer-filed report.
 
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Brand Name
AMS MONARC SLING SYSTEM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
sharon zurn, dir
10700 bren road west
minnetonka, MN 55343
9529306347
MDR Report Key4383525
MDR Text Key15126709
Report Number2183959-2014-77213
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
K023516
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Not Applicable
Type of Report Initial
Report Date 11/05/2014
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? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 11/05/2014
Initial Date FDA Received12/31/2014
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) Death;
Patient Age35 YR
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