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

Model Number UML1

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 09/29/2021

Event Type  malfunction  

Event Description

It was reported that the mesh was delivered on (b)(6) 2021.It was reported that upon delivery both the carton and the inner packaging were torn.It was reported that the device was not used.There were no adverse patient consequences reported.

Manufacturer Narrative

Product complaint # (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.A manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.Evaluation: a photo of a damaged box and sample was observed.The photo did not provide enough evidence to determine the root cause.An opened cardboard box and sealed foil pouch of product were returned for analysis.Upon initial inspection of the box received, damage (cross cut) was observed and the foil pouch was observed with the same condition as if the cross cut was made when the foil pouch still into the box.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.No conclusion could be reached as to what caused the reported complaint.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12720593
• MDR Text Key: 281426137
• Report Number: 2210968-2021-10590
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132399
• UDI-Public: 10705031132399
• 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,health professional
• Type of Report: Initial
• Report Date: 10/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UML1
• Device Catalogue Number: UML1
• Device Lot Number: REBCRZC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2021
• Date Manufacturer Received: 09/30/2021
• Patient Sequence Number: 1