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

Model Number UPA31515

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

Patient Problems Diarrhea (1811); Nausea (1970); Chills (2191)

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.

Event Description

It was reported by an attorney that the patient underwent removal surgery an recurrent hernia repair surgery on (b)(6) 2018 and the mesh was implanted during which the surgeon noted the previous mesh was protruding and was excited from the edges of the fascia.It was reported that the patient experienced severe pain, nausea, diarrhea, chills, inflammation, loss of appetite, and extreme weight loss.It was reported that the patient previously underwent hernia repair surgery on (b)(6) 2008 and proceed was implanted.Other procedure is captured in a separate file.No additional information was provided.

• Brand Name: ULTRAPRO ADVANCED
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• Manufacturer (Section G): ETHICON INC.-GMBH; p.o. box 1409; norderstedt D2284 1; GM D22841
• Manufacturer Contact: elba bello ; p.o. box 151, route 22 west; somerville, NJ 08876 ; 9082183429
• MDR Report Key: 10912566
• MDR Text Key: 219366930
• Report Number: 2210968-2020-09408
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031237001
• UDI-Public: 10705031237001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/23/2020

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
• Device Operator: Health Professional
• Device Model Number: UPA31515
• Device Catalogue Number: UPA31515
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/19/2020
• Initial Date FDA Received: 11/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1