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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ASTORA WOMEN'S HEALTH LLC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC
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ASTORA WOMEN'S HEALTH LLC AMS MONARC SLING SYSTEM; MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Death (1802); Incontinence (1928); Unspecified Infection (1930); Pain (1994); Prolapse (2475)
Event Date 12/13/2007
Event Type  Death  
Event Description
It was reported by the plaintiff's attorney that the plaintiff allegedly experienced pain, infections, incontinence, prolapse and bladder leakage.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to manufacturer report #: 3011770902-2016-00173, 3011770902-2016-00174.
 
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Brand Name
AMS MONARC SLING SYSTEM
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ASTORA WOMEN'S HEALTH LLC
13200 pioneer trail
suite 100
eden prairie MN 55347
Manufacturer (Section G)
ASTORA WOMEN'S HEALTH LLC
13200 pioneer trail
suite 100
eden prairie MN 55347
Manufacturer Contact
erika a. merrick
13200 pioneer trail
suite 100
eden prairie, MN 55347
9522383906
MDR Report Key5578737
MDR Text Key42709292
Report Number3011770902-2016-00175
Device Sequence Number1
Product Code OTN
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2016
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
Initial Date Manufacturer Received 04/11/2016
Initial Date FDA Received04/14/2016
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
Treatment
MONARC
Patient Outcome(s) Death;
Patient Age70 YR
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