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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH MESH

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MESH MESH Back to Search Results
Device Problem Device Dislodged or Dislocated (2923)
Patient Problems Abdominal Pain (1685); Incontinence (1928); Constipation (3274)
Event Date 07/08/2013
Event Type  Injury  
Event Description
After hernia repair (abdominal-open) i began having extreme abdominal pain; unable to clean out for a colonoscopy; fecal incontinence for weeks; build up for almost two weeks. Passing bms so large, i pulled rectal mesh. I'm in so much pain; have mesh in four places and treated for chronic pain and now, home w/o any treatment.
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Brand NameMESH
Type of DeviceMESH
MDR Report Key5366288
MDR Text Key35990074
Report NumberMW5059329
Device Sequence Number1
Product Code FTM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 01/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 01/10/2016 Patient Sequence Number: 1