MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	UMM3
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Pain (1994); Not Applicable (3189)
Type of Reportable Event	Serious Injury
Additional 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.In addition, a review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.
Event or Problem Description
It was reported that the patient underwent an inguinal hernia repair procedure in (b)(6) 2014 and mesh was implanted.The patient reported that they experienced sharp pain in the groin area and went to the emergency room in (b)(6) 2017.The mesh was removed from several places inside of the patient in (b)(6) 2018.Additional information will be requested.
Additional Manufacturer Narrative
It was reported that the patient underwent a hernia repair surgery on (b)(6)2014.No additional information was provided.

• 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: 7320813
• Report Number: 2210968-2018-71328
• Device Sequence Number: 10793120
• Product Code: FTL
• UDI-Device Identifier: 10705031132481
• UDI-Public: 10705031132481
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: UMM3
• Device Lot Number: HD8HJKS0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2018
• Supplement Date Received by Manufacturer: 07/11/2018
• Initial Report FDA Received Date: 03/07/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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