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

Catalog Number	UHSL
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).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 hernia repair on an unknown date in 2019 and the mesh was implanted.It was reported that the mesh inside the packaging did not match what was labeled on the outside.The case completed with the mesh.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Evaluation: an empty opened foil of product and an empty opened folder of product were returned for evaluation.During the visual inspection of the packets, it was noted that the product is according to the finish good requirements. the manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.According to the sample condition, no packaging labeling identification issue was found.

• Brand Name: ULTRAPRO HERNIA SYSTEM 10CM UNDERLAY
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8833434
• Report Number: 2210968-2019-84717
• Device Sequence Number: 2754879
• Product Code: FTL
• UDI-Device Identifier: 10705031132450
• UDI-Public: 10705031132450
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071249
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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 Expiration Date: 07/31/2020
• Device Catalogue Number: UHSL
• Device Lot Number: MJ8CHXB1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2019
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/26/2019
• Supplement Report FDA Received Date: 09/06/2019
• Patient Sequence Number: 1