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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MESH

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MESH Back to Search Results
Device Problems Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Patient Problems Abscess (1690); Fatigue (1849); Fever (1858); Unspecified Infection (1930); Pain (1994); Cramp(s) (2193)
Event Date 03/31/2017
Event Type  Injury  
Event Description
The reporter stated that she has had abdominal pain ever since the mesh was put in, but in (b)(6) of this year she had a terrible cold, and her right side pain got worse and worse. She went to (b)(6) and they could not do anything and sent her to (b)(6). At (b)(6) they said the mesh was floating around. They gave her antibiotics and put a drain in. She was in the hospital for 8 days. Four to six weeks later, she had a fever and her midriff on the right side was hard as a rock. They put in another drain and said she has 2 spots with an abscess and infection that would not clear up. That is when she was taken for a 7 hour surgery and the mesh was removed and the hernia corrected again. The pain is better but still having cramps when standing up or making certain movements and energy level is down. No get up and go.
 
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Brand NameMESH
Type of DeviceMESH
MDR Report Key6914006
MDR Text Key88255673
Report NumberMW5072601
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/03/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/04/2017 Patient Sequence Number: 1
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