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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC

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ETHICON, INC. PROLENE MESH MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abdominal Pain (1685); Nerve Damage (1979); Pain (1994)
Event Date 04/12/2013
Event Type  Injury  
Event Description
Staples were used with mesh during hernia repair. I have had pain in my left lower abdominal area extending down my leg into the groin area. I have been told by two surgeons, based on cts and x-ray, a nerve is stapled and advised of the complications that are possible if the staple were removed. I now have chronic pain in that area. Fda safety report id# (b)(4).
 
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Brand NamePROLENE MESH
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON, INC.
MDR Report Key12624424
MDR Text Key278368394
Report NumberMW5104560
Device Sequence Number1
Product Code FTL
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 10/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
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

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