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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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AMERICAN MEDICAL SYSTEMS, INC. AMS MINIARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Catalog Number 720046-01
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Death (1802); Incontinence (1928); Scar Tissue (2060); Discharge (2225)
Event Date 06/13/2011
Event Type  Death  
Event Description
It was reported by the plaintiff experienced urethral sling erosion, discharge, scarring and stress urinary incontinence.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report#: 2183959-2014-44651.
 
Manufacturer Narrative
This was initially reported on the summary report dated august 30, 2014 under exemption (b)(4).Additionally, this was reported on the summary report date october 30, 2014 under exemption (b)(4).Layer-filed report.
 
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Brand Name
AMS MINIARC 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, director
10700 bren road west
minnetonka, MN 55343
9529306347
MDR Report Key4383550
MDR Text Key5291979
Report Number2183959-2014-42557
Device Sequence Number1
Product Code PAH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K071902
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 12/13/2012
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
Device Expiration Date12/16/2012
Device Catalogue Number720046-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/13/2012
Initial Date FDA Received12/31/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
PERIGEE
Patient Outcome(s) Death;
Patient Age31 YR
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