MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED MESH 15X15CM; MESH, SURGICAL, POLYMERIC

Model Number	UPA1515
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/23/2019
Type of Reportable Event	Malfunction
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 retrieve the device.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 an inguinal hernia repair procedure on (b)(6) 2019 and the mesh was implanted.It was reported that the top left side of the packaging did not appear to be sealed all the way.A like device was used to complete the procedure.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 02/04/2020.H3 evaluation: one partially open sample of product code upa31515 was received for analysis.During visual inspection of the sample, the foil was open of the peelable area.A light seal mark was noted at the top and bottom foil which indicates that the package was sealed.Also, the seal margin met with the requirement.In addition, wrinkles on the top left side of the packet due to manipulation of the package could be observed.The manufacturing records were reviewed, and the manufacturing/packaging criteria were met prior to the release of this batch.Per the sample condition, it could not be determined what may have caused the reported incident.Additional information was requested and the following was obtained: was there an issue with second device that was implanted? no.Are any pictures of the product available? no.What is the patient¿s current status? good no issues.

• Brand Name: ULTRAPRO ADVANCED MESH 15X15CM
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9612660
• Report Number: 2210968-2020-00550
• Device Sequence Number: 11447719
• Product Code: FTL
• UDI-Device Identifier: 10705031236967
• UDI-Public: 10705031236967
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2019

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: 06/30/2021
• Device Model Number: UPA1515
• Device Catalogue Number: XCUPA1515
• Device Lot Number: PHCCZHB0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 12/27/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 01/21/2020
• Supplement Report FDA Received Date: 02/05/2020
• Patient Sequence Number: 1