MAUDE Adverse Event Report: ETHICON INC. PROLENE* HERNIA SYSTEM; MESH, SURGICAL, POLYMERIC

Catalog Number PHSL

Device Problem Failure To Adhere Or Bond (1031)

Patient Problems Nerve Damage (1979); Pain (1994); Scar Tissue (2060); Swelling (2091); No Code Available (3191)

Event Date 04/30/2013

Event Type  Injury  

Manufacturer Narrative

(b)(4) date sent to fda: 10/18/2016.(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.The following information has been requested, but no response has been received.Should any additional information be provided, a supplemental 3500a will be sent: if in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation?.

Event Description

It was reported that the patient underwent a left inguinal hernia repair procedure in 2013 and mesh was implanted.The patient reported that they have suffered from severe swelling and pain in the left groin area since the surgery.The patient later underwent exploratory surgery to see what the problem was.It was found that the mesh had come undone on the ends and shrunk into a ball.The mesh was removed and the hernia was repaired.The patient now experiences severe swelling, nerve damage, scar tissue damage and dyspareunia.The pain goes to the left testicle which may have to be removed due to low blood flow to that area of the body.The patient received prescriptions for inflammation and pain.However, the patient no longer takes the anti-inflammatory due to kidney issues.Maude report #: mw5064349.

Manufacturer Narrative

Additional information was requested and the following was received: the patient underwent an open left inguinal hernia repair in (b)(6) 2013 and mesh was implanted.The mesh was removed in (b)(6) 2015.

• 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): DEFAULT ORGANIZATION; 4545 creek rd ml # 36; cincinnati OH 45242 2803
• Manufacturer Contact: krystina laguna ; route 22 westp o box 151; somerville, NJ 08876 ; 9082183043
• MDR Report Key: 6036301
• MDR Text Key: 57708428
• Report Number: 2210968-2016-14402
• Device Sequence Number: 1
• Product Code: FTL
• Combination Product (y/n): N
• PMA/PMN Number: K984220
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: PHSL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention