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

Model Number	UPA31015
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Packaging Problem (3007)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.
Event or Problem Description
It was reported that the mesh was used prior to an unknown procedure on an unknown date.It was reported that the ultrapro mesh showed perforation of inner packaging.It was reported that the sterility might be compromised.There were no adverse patient consequences reported.
Additional Manufacturer Narrative
Product complaint # (b)(4).Date sent to the fda: 12/11/2020.Additional information: d9, h6, h3 evaluation: an opened foil packet, a paper folder with product were returned for evaluation.During the visual inspection of sample, several wrinkles and twenty holes could be observed on foil packet, the holes appear to be caused from outside to inside and on the wrinkles.The mesh was examined and was not observed with damaged or degradation.Per the condition of the sample received, it was suggest excessive manipulation of foil packet.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.

• 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: 10840639
• Report Number: 2210968-2020-09048
• Device Sequence Number: 3525619
• Product Code: FTL
• UDI-Device Identifier: 10705031236998
• UDI-Public: 10705031236998
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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: 03/31/2022
• Device Model Number: UPA31015
• Device Catalogue Number: UPA31015
• Device Lot Number: QDBCKSD0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 11/13/2020
• Supplement Report FDA Received Date: 12/11/2020
• Patient Sequence Number: 1