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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AMERICAN MEDICAL SYSTEMS (MN) UNKNOWN SLING
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AMERICAN MEDICAL SYSTEMS (MN) UNKNOWN SLING Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Dehydration (1807); Anxiety (2328); Depression (2361); Palpitations (2467); Sleep Dysfunction (2517); Weight Changes (2607)
Event Date 05/10/2008
Event Type  Injury  
Event Description
It was reported that following the implantation of an unknown bladder sling the patient experienced an "erosion of mesh", had multiple surgeries to remove the mesh, ileostomy, "nonfunction of large intestines", dehydration, "severe weight loss", depression, anxiety, "medication to cope with medical tribulation", sleep depravation, heart palpitation.No further complications have been reported in relation to this event.
 
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Brand Name
UNKNOWN SLING
Type of Device
UNKNOWN
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 Key4899229
MDR Text Key6016994
Report Number2183959-2015-00292
Device Sequence Number1
Product Code OTN
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,Consumer
Reporter Occupation Other
Type of Report Initial
Report Date 06/24/2015
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? No
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/24/2015
Initial Date FDA Received07/08/2015
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) Hospitalization; Required Intervention;
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