MAUDE Adverse Event Report: ETHICON INC. PROLENE 3D PATCH LGE DIAM (5CM), EXT; MESH, SURGICAL, POLYMERIC

Model Number	3DPL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); Pain (1994); Hernia (2240)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported by an attorney that the patient underwent an umbilical hernia repair surgery on (b)(6) 2012 and mesh was implanted.It was reported that the patient underwent a removal surgery with wound debridement and repair of an incisional hernia on (b)(6) 2016.It was reported that during the surgery, the surgeon noted ¿an abscess and a tract that led from the skin down to the obvious palpable visible mesh.The fistula tract was cored out to expose the fascia and the mesh was excised.¿ it was reported the wound was packed and left open to heal by secondary intent.It was reported patient underwent a laparotomy with removal of the remaining infected mesh material and lysis of adhesions on (b)(6) 2016.It was reported patient presented to er on (b)(6) 2016 with severe pain, tachycardia, an enterocutaneous fistula and a thickened loop of small bowel.No details are provided regarding treatment received during this hospital stay of three days.It was reported patient underwent recurrent umbilical hernia repair surgery on (b)(6) 2017; however no details are provided from this surgical procedure.It was reported the patient continues to experience severe pain, hospitalizations, hernia recurrence, inflammation, infection and fistula, limitations on physical activity, multiple removal surgeries and stress and anxiety.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda; (b)(4) 2018.In addition, a device history review has been inserted into the file.This review indicates that there was no quality concerns associated with the manufacturing process.
Additional Manufacturer Narrative
Date sent to fda: 08/28/2020.

• Brand Name: PROLENE 3D PATCH LGE DIAM (5CM), EXT
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7961260
• Report Number: 2210968-2018-75960
• Device Sequence Number: 13824966
• Product Code: FTL
• UDI-Device Identifier: 10705031005143
• UDI-Public: 10705031005143
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K010722
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/15/2018

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
• Operator of Device: No Information
• Device Expiration Date: 01/31/2016
• Device Model Number: 3DPL
• Device Catalogue Number: 3DPL
• Device Lot Number: 23639-01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/21/2018
• Supplement Date Received by Manufacturer: 10/15/2018; 08/27/2020
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 10/16/2018; 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention