MAUDE Adverse Event Report: ETHICON INC. PROLENE MESH 1INX4IN; MESH, SURGICAL, POLYMERIC

Model Number	PMXS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
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 revision surgery on (b)(6) 2007 and two (2) mesh products were implanted during which the surgeon noted ¿scarring of the conjoined tendon in the left groin and it was attached to the mesh¿.It was reported that the patient had previously underwent left inguinal hernia repair surgery on (b)(6) 2006 and mesh was implanted.It was reported that the patient experienced left groin pain.Other procedure is captured in a separate file.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 12/28/2020.Additional information: a2, b7, d3, g1.

• Brand Name: PROLENE MESH 1INX4IN
• 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: 8860806
• Report Number: 2210968-2019-84547
• Device Sequence Number: 13607508
• Product Code: FTL
• UDI-Device Identifier: 10705031049079
• UDI-Public: 10705031049079
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K962530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: Health Professional
• Device Model Number: PMXS
• Device Catalogue Number: PMXS
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/18/2019
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 12/28/2020
• 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