MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Model Number UMS3

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/22/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).(b)(4.) no additional information is available.If further details are received at a later date a supplemental medwatch will be sent.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that a patient underwent an inguinal hernia repair procedure on (b)(6) 2021 and the mesh was implanted.It was reported that the hernia mesh had large holes and there is high possibility of the hernia mesh shedding.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 06/27/2021.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.  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.Product complaint # (b)(4).Date sent to the fda: 06/27/2021.Corrected information: d4 - lot.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.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 11904007
• MDR Text Key: 266932092
• Report Number: 2210968-2021-05075
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031085947
• UDI-Public: 10705031085947
• Combination Product (y/n): N
• PMA/PMN Number: K033337
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: UMS3
• Device Catalogue Number: UMS3
• Device Lot Number: QBBDMRA0
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/30/2021
• Initial Date FDA Received: 05/28/2021
• Supplement Dates Manufacturer Received: 05/31/2021
• Supplement Dates FDA Received: 06/27/2021
• Patient Sequence Number: 1