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

Model Number UPA31015

Device Problems Delivered as Unsterile Product (1421); Packaging Problem (3007)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2020

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.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in (b)(6) 2020.It was reported that the ultrapro net shows perforation on the inner aluminium packaging.It was also reported that the sterility of product is not guaranteed anymore.There was no surgery impact since another mesh was available.There were no adverse patient consequences reported and no patient harm.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 12/17/2020.H3 evaluation: one open foil and one mesh inside a folder of product was received for analysis.During visual inspection of the foil packet it was observed that multiples wrinkles and holes on bottom foil were due to excessive manipulation.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 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
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 10820520
• MDR Text Key: 216383480
• Report Number: 2210968-2020-08935
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031236998
• UDI-Public: 10705031236998
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: UPA31015
• Device Catalogue Number: UPA31015
• Device Lot Number: QHBBQRD0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 11/23/2020
• Supplement Dates FDA Received: 12/17/2020
• Patient Sequence Number: 1