MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED; MESH, SURGICAL, POLYMERIC

Model Number	UPA3030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); 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.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 on (b)(6) 2018 and mesh was implanted during which the surgeon noted ¿dense bowel adhesions.The transverse colon was densely adhered to the anterior abdominal wall.There were considerable adhesions of transverse colon, omentum and small bowel to the abdominal wall, in the mid-abdomen.¿ it was reported that the patient experienced severe pain and chronic abdominal pain.The patient had a previous mesh implanted on (b)(6) 2010.Other implanted product is captured under a separate file.No additional information is provided.
Additional Manufacturer Narrative
Date sent to the fda: 10/16/2020.

• Brand Name: ULTRAPRO ADVANCED
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1210 ward avenue; west chester PA 19380
• MDR Report Key: 9191336
• Report Number: 2210968-2019-88352
• Device Sequence Number: 19482747
• Product Code: FTL
• UDI-Device Identifier: 10705031236981
• UDI-Public: 10705031236981
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2019

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 Expiration Date: 12/31/2019
• Device Model Number: UPA3030
• Device Catalogue Number: UPA3030
• Device Lot Number: MA9CKBA0
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 10/16/2020
• 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