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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Adhesion(s) (1695); Muscle Spasm(s) (1966); Nerve Damage (1979); Pain (1994); Cramp(s) (2193); Discomfort (2330); 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 a laparoscopic abdominal hernia repair procedure in (b)(6) 2011 and mesh was implanted.The patient reported that they experienced extreme pain for five days following the procedure which increased in severity for about six weeks.The patient was prescribed pain killers and anti-inflammatory medication.The patient was seen for follow up about five weeks after the procedure.The patient reported they were informed that a new kind of suture had been used which may be the cause for the severe pain.The name or type of suture was not provided.In (b)(6) 2012, the patient experienced contortions initiated by movement, chronic pain, subsequent discomfort and other negative effects that continued around the area of surgery.The patient reported that the surgeon believes the issues experienced are related to irritable bowel syndrome, but the patient believes the hernia procedure is the cause.The patient reported that this has effected the ability to work, overall lifestyle and mental health.The patient has undergone multiple tests including mri, ct, x ray and pain management assessments.The patient reported that they underwent another unspecified laparoscopic procedure on an unknown date.The patient reported that another surgeon has concluded that these issues are due to adhesion formation, nerve damage and the length of time that the mesh has been in place.The same surgeon also believes no surgical resolution is possible and that pain management is the best possibility.On (b)(6) 2017, the patient had a spinal cord stimulator implant to help their condition.The patient reported that the stimulator manages about 40% of the chronic pain, but there are regular occasions where the patient experiences flare points.The patient reported that the trigger point location is always painful and the movement initiated contortions, cramping and extreme pain episodes can last up to 8 minutes with subsequent residual pain lasting for at least 72 hours.The mesh remains implanted.No additional information has been provided.

• 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 Key: 7500328
• MDR Text Key: 107820447
• Report Number: 2210968-2018-72692
• 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,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 Received: 05/09/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention