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

Model Number UPA37615

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/07/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Additional information was requested and the following was obtained: please provide procedure name and date, open inguinal tuesday sept 7.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail, no adverse consequences because the product was not used.How was procedure successfully completed? opened another device.Please provide status of product return.No return.The product was returned to ethicon inc for evaluation.Visual inspection was conducted on the returned device.Visual analysis of the sample received determined that one top foil packet and an opened folder with the product was received for evaluation.The foil was visually inspected, and excessive wrinkles and a hole that appeared to be caused by the wrinkles was noted.As part of our quality process, the manufacturing records of this lot-serial number were reviewed, and the manufacturing standards were met prior to the release of this batch.Additional complaint information monitoring for potential safety signals will be conducted through complaint trending as part of post-market surveillance.

Event Description

It was reported that a patient underwent an inguinal hernia repair on (b)(6) 2021 and the mesh was used.It was reported that there was a pin-sized hole in the packaging of the device.There were no adverse patient consequences reported.Additional information was requested.

• Brand Name: ULTRAPRO ADVANCED
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12585039
• MDR Text Key: 281145128
• Report Number: 2210968-2021-09271
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031237025
• UDI-Public: 10705031237025
• Combination Product (y/n): N
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 09/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: UPA37615
• Device Catalogue Number: UPA37615
• Device Lot Number: QCBCHSCO
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2021
• Date Manufacturer Received: 09/08/2021
• Patient Sequence Number: 1