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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH
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AMERICAN MEDICAL SYSTEMS (MN) AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE; SURGICAL MESH Back to Search Results
Device Problem Malposition of Device (2616)
Patient Problems Incontinence (1928); Pain (1994); Discomfort (2330); Constipation (3274)
Event Date 06/17/2013
Event Type  Injury  
Event Description
Related to mfg.Report no.: 2183959-2014-00251.It was reported the patient had an elevate anterior graft implanted on (b)(6) 2013 for pelvic organ prolapse.Since then, the patient has experienced great pelvic discomfort, incontinence, problems having a complete bowel movement as well as inability to have intercourse.The patient was seen by a local physician who "determined that the mesh was hanging down." no further patient complications were reported in relation to this event.
 
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Brand Name
AMS ELEVATE ANTERIOR PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE
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 Key3902519
MDR Text Key16779906
Report Number2183959-2014-00250
Device Sequence Number1
Product Code OTP
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 Other
Reporter Occupation Other
Type of Report Initial
Report Date 06/02/2014
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
Initial Date Manufacturer Received 06/02/2014
Initial Date FDA Received06/30/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
MINIARC
Patient Outcome(s) Required Intervention;
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