MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number	UHSM
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Not Applicable (3189)
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.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.
Event or Problem Description
It was reported by an attorney that the patient underwent hernia repair surgery and mesh was implanted on (b)(6) 2011.It was reported that the patient underwent a hernia repair procedure on (b)(6) 2012 and mesh was implanted.It was reported the patient experienced an undisclosed adverse event.No additional information was provided.
Additional Manufacturer Narrative
Date sent to the fda: 02/24/2020.

• Brand Name: ULTRAPRO HERNIA SYSTEM 7.5CM UNDERLAY
• 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: 8225499
• Report Number: 2210968-2018-77897
• Device Sequence Number: 2267045
• Product Code: FTL
• UDI-Device Identifier: 10705031132467
• UDI-Public: 10705031132467
• Combination Product (Y/N): N
• PMA/510(K) Number: K071249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2018

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: 02/28/2013
• Device Model Number: UHSM
• Device Catalogue Number: UHSM
• Device Lot Number: DC8MHZA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/18/2018
• Supplement Date Received by Manufacturer: 02/24/2020
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 02/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR