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

Catalog Number	UPA37615
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 inc, 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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned samples determined that it was received, one empty opened foil that pertain to product code upa37615.The foil was visually inspected, and wrinkles and one hole in the cavity were observed.The reported event is confirmed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.Related events captured via 2210968-2023-07037 and 2210968-2023-07038.
Event or Problem Description
It was reported that a patient underwent a hernia repair procedure on (b)(6) 2023 and mesh was used.Upon opening the package, the circulating nurse noticed the package had a hole in it.Another like device was used to continue with the procedure.Product was not used on the patient.There were no adverse consequences.No further information was provided.
Additional Manufacturer Narrative
(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 inc, 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.Additional information received: the foil packets are typically stored individually.For each case, the staff pulls several different sizes of mesh.The surgeon will then select the appropriate size based on the hernia defect.The unused sizes of mesh are returned to the shelf/drawer.(b)(4).Corrected information: h6.

• Brand Name: ULTRAPRO ADVANCED
• 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 ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17812396
• Report Number: 2210968-2023-07037
• Device Sequence Number: 6953593
• Product Code: FTL
• UDI-Device Identifier: 10705031237025
• UDI-Public: 10705031237025
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup

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: 06/30/2024
• Device Catalogue Number: UPA37615
• Device Lot Number: SHBDCBC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2023
• Supplement Date Received by Manufacturer: 11/03/2023
• Initial Report FDA Received Date: 09/25/2023
• Supplement Report FDA Received Date: 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2022
• 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