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

Model Number UMR3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Cramp(s) (2193); No Code Available (3191)

Event Type  Injury  

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 review of the manufacturing records was performed and indicates that there were no quality concerns associated with the manufacturing process.

Event Description

It was reported by an attorney that the patient had removal surgery on (b)(6) 2017 during which ¿the left half of the hernia sac was comprised of mesh that had not incorporated into the anterior abdominal wall¿ and mesh was implanted.It was reported that the patient experienced pain, stomach cramping, trouble digesting food and difficulty regulating bowel functions.No additional information is provided.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8345660
• MDR Text Key: 136454166
• Report Number: 2210968-2019-78813
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132498
• UDI-Public: 10705031132498
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 02/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: UMR3
• Device Catalogue Number: UMR3
• Device Lot Number: LA8BGXB0
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention