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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC/ COVIDIEN PARIETEX HERNIA MESH MESH, SURGICAL, POLYMERIC

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MEDTRONIC/ COVIDIEN PARIETEX HERNIA MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Folded (2630)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Date 09/08/2014
Event Type  Injury  
Event Description
A surgeon implanted a 15x13cm covidien parietex mesh for my small inguinal hernia. I got severe abdominal and groin pain. Had two surgeries to get it removed, but still in terrible pain. The mesh had crumbled and folded.
 
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Brand NamePARIETEX HERNIA MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
MEDTRONIC/ COVIDIEN
MDR Report Key7108620
MDR Text Key94667406
Report NumberMW5073914
Device Sequence Number1
Product Code FTL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 12/08/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No Answer provided
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: 12/11/2017 Patient Sequence Number: 1
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