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

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.

• 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.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 8082054
• MDR Text Key: 127542135
• Report Number: 2210968-2018-77220
• Device Sequence Number: 1
• Product Code: FTM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• 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 Received: 11/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR