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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS, INC. UNKNOWN GRAFT MESH
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AMERICAN MEDICAL SYSTEMS, INC. UNKNOWN GRAFT MESH Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problems Erosion (1750); Death (1802); Fistula (1862); Pain (1994); Urinary Tract Infection (2120); Discharge (2225); Discomfort (2330); Prolapse (2475)
Event Date 12/01/2008
Event Type  Death  
Event Description
It was reported by the plaintiff's attorney that the plaintiff experienced discomfort, vaginal pain, rectovaginal fistula, erosion, urinary tract infection, recurrent prolapse and vaginal bulge, solid fecal incontinence, diverticulosis with necrotic diverticulum, pain in the lower abdomen/vaginal area, foul smelling discharge, vaginal discharge, vaginal foreign body and left vulvar lesion.Furthermore, it was reported that the plaintiff died.No cause of death was reported.Related to mfr report #: 2183959-2015-54509.
 
Manufacturer Narrative
(b)(4).
 
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Brand Name
UNKNOWN GRAFT MESH
Type of Device
NA
Manufacturer (Section D)
AMERICAN MEDICAL SYSTEMS, INC.
10700 bren road west
minnetonka MN 55343
Manufacturer Contact
sharon zurn, dir qlty compliance
10700 bren road west
minnetonka, MN 55343
9529306347
MDR Report Key4920782
MDR Text Key6053664
Report Number2183959-2014-45249
Device Sequence Number1
Product Code OTM
Combination Product (y/n)N
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 06/25/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/15/2015
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
Date Manufacturer Received06/25/2014
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
Treatment
PERIGEE
Patient Outcome(s) Death;
Patient Age77 YR
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