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

Model Number	UPA31015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Unspecified Infection (1930)
Date of Event	10/22/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).The device history records were reviewed, and the manufacturing criteria was met prior to the release of this lot.To date, the device has not been returned.If the device, or further details are received at a later date, a supplemental medwatch will be sent.
Event or Problem Description
It was reported that a patient underwent a bilateral inguinal hernia surgery using the tapp method on (b)(6) 2020, and the mesh was implanted.It was reported that the patient returned to the hospital on (b)(6) 2020, and it appears that in one groin of his, there is an abscess resulting from an infection that caused in the operating.An examination performed at the hospital revealed that there was a presence of the bacterium mycobacterium goodii in the area of the abscess.According to the doctor, this bacterium is not usually present in the body, and its presence raises suspicion that it can be originated in the equipment used during the operation.It was reported that the doctor who received the patient after his return to the hospital, said that it is not known about a direct link between the development of the abscess / the presence of the bacterium, and between the mesh that was used to repair the hernia.In his view, at this stage there is a possibility that any other tool that was used in the surgery might have caused the infection.It was reported that after the patient returned to the hospital, an abscess drainage procedure was performed, and tests were taken.It was also reported that currently the patient is hospitalized at beilinson hospital with a hole in the groin area that made in order to drain of the abscess.It was reported that the doctors are trying to treat the infection through conservative treatment.

• Brand Name: ULTRAPRO ADVANCED
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10906703
• Report Number: 2210968-2020-09284
• Device Sequence Number: 3007070
• Product Code: FTL
• UDI-Device Identifier: 10705031236998
• UDI-Public: 10705031236998
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K070224
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/26/2020

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: 01/31/2022
• Device Model Number: UPA31015
• Device Catalogue Number: UPA31015
• Device Lot Number: QBCDPJC0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2020
• Initial Report FDA Received Date: 11/25/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention