MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO PLUG (MEDIUM); MESH, SURGICAL, POLYMERIC

Model Number	UPPM6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Swelling/ Edema (4577)
Date of Event	09/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on an unknown date a year ago and the mesh was implanted.It was reported that the patient was having pain.It was also reported that on (b)(6) 2021 the patient's doctor found a bulge in the patient's abdomen and recommended removal of the mesh.Additional information has been requested.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.If in your possession, may we have a copy of your operative report? does ethicon have your permission to contact your surgeon, in the event ethicon would like to contact your surgeon for more clinical information to be used for a product quality complaint investigation? if so, please provide your surgeon¿s name, contact information and sign release of medical information form attached.

• Brand Name: ULTRAPRO PLUG (MEDIUM)
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12694139
• Report Number: 2210968-2021-10280
• Device Sequence Number: 4446374
• Product Code: FTL
• UDI-Device Identifier: 10705031132597
• UDI-Public: 10705031132597
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 11/30/2015
• Device Model Number: UPPM6
• Device Catalogue Number: UPPM6
• Device Lot Number: GP8BKWBO
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2021
• Initial Report FDA Received Date: 10/25/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention