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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHICON MESH UNKNOWN MESH, SURGICAL, POLYMERIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Nerve Damage (1979); Pain (1994); Swelling (2091); Ambulation Difficulties (2544)
Event Date 07/01/2015
Event Type  Injury  
Manufacturer Narrative
(b)(4). To date the device has not been returned. If the device or further details are received at the later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an inguinal hernia repair on (b)(6) 2015 and the mesh was implanted. Six months later, the patient started having pain in her groin area and right leg start swelling. The patient described that her right leg feels like it is wet but no fluid seeping out, the leg is just swollen and constantly hurts. The patient cannot put any weight on the leg. The patient followed up with her primary doctor. The doctor opined that the mesh is causing the swelling, pain and difficulty walking that she is experiencing, and he indicated that the mesh caused the nerve damage. The patient cannot lift more than 5 pounds. The patient stated that she is pretty much swollen everywhere but primarily in her right leg. It was also reported that the patient is seeing a doctor for pain and was prescribed vicodin once daily. The device remains implanted. No further information has been requested.
 
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Brand NameETHICON MESH UNKNOWN
Type of DeviceMESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key8082054
MDR Text Key127542135
Report Number2210968-2018-77220
Device Sequence Number1
Product Code FTM
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial
Report Date 11/05/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/17/2018
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?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/05/2018
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?
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/17/2018 Patient Sequence Number: 1
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