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

Model Number	UML1
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.

• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• MDR Report Key: 12720593
• Report Number: 2210968-2021-10590
• Device Sequence Number: 3706101
• Product Code: FTL
• UDI-Device Identifier: 10705031132399
• UDI-Public: 10705031132399
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/29/2021

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?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/29/2021
• Patient Sequence Number: 1