MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number	UHSL
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc., or its employees that the report constitutes an admission that the product, ethicon, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).The following information was requested, but unavailable: please provide lot number? are there pictures of the damaged device available? no device will be returning for this case.If further details are received at a later date a supplemental medwatch will be sent.Event associated with ultrapro hernia system reported.Event associated with ultrapro plug reported via mw# 2210968-2022-06813.
Event or Problem Description
It was reported that a patient underwent an unknown procedure on an unknown date and the mesh was used.It was reported that the size of the product is not written on the package so the surgeon is confused.It was reported that another device was used to complete the case.There were no adverse consequences to the patient.Additional information was requested.

• Brand Name: ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt 22841 ; GM 22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 15271317
• Report Number: 2210968-2022-06812
• Device Sequence Number: 6494141
• Product Code: FTL
• UDI-Device Identifier: 10705031132450
• UDI-Public: 10705031132450
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K071249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: UHSL
• Device Catalogue Number: UHSL
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2022
• Initial Report FDA Received Date: 08/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown