MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number	UHSL6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adhesion(s) (1695); Hernia (2240); Discomfort (2330)
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.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.(b)(4) submitted for adverse event which occurred on (b)(6) 2017.
Event or Problem Description
It was reported by an attorney that the patient underwent a hernia repair procedure on (b)(6) 2016 and mesh was implanted.It was reported that the patient underwent partial removal surgeries on (b)(6) 2017 and (b)(6) 2017.It was reported that the patient experienced adhesion, discomfort, pain, hernia and neuralgia.No additional information was provided.
Additional Manufacturer Narrative
Date sent to fda: (b)(6) 2020.Additional information: d4, h4.A review of the batch manufacturing records was conducted and the batch met all finished goods release criteria.

• Brand Name: ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10382043
• Report Number: 2210968-2020-05940
• Device Sequence Number: 19625203
• Product Code: FTL
• UDI-Device Identifier: 10705031132566
• UDI-Public: 10705031132566
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/05/2020

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: 08/31/2017
• Device Model Number: UHSL6
• Device Catalogue Number: UHSL6
• Device Lot Number: JK8CQKA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2020
• Supplement Date Received by Manufacturer: 08/10/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/12/2020
• 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