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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 Hypersensitivity/Allergic reaction (1907); Nerve Damage (1979); Pain (1994); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
(b)(4).To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.
 
Event Description
It was reported that the patient underwent an unknown procedure on an unknown date and mesh was implanted.The patient reported experiencing immediate allergic reaction to the mesh, severe allodynia and significant long-term nerve damage in groin, leg, vaginal area.The mesh was removed in (b)(6) 2013.No additional information has been provided.
 
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Brand Name
ETHICON MESH UNKNOWN
Type of Device
MESH, SURGICAL, POLYMERIC
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876 0151
Manufacturer (Section G)
ETHICON INC.
p.o. box 151, route 22 west
somerville 08876 0151
Manufacturer Contact
darlene kyle
p.o. box 151, route 22 west
somerville, NJ 08876-0151
9082182792
MDR Report Key7506467
MDR Text Key108012037
Report Number2210968-2018-72727
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,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 04/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/11/2018
Initial Date FDA Received05/11/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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