MAUDE Adverse Event Report: ETHICON INC. PROCEED*SURG MESH/MULTI LYR; MESH, SURGICAL, POLYMERIC

Model Number PCDH1

Device Problem Delivered as Unsterile Product (1421)

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

Event Type  malfunction  

Manufacturer Narrative

Product complaint # pc-(b)(4).A manufacturing record evaluation was performed for the finished device lot, and no non-conformance's were identified.Additional information was requested and the following was obtained: please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail.The device was not used on the patient.Evaluation: a visual analysis of an image received.According to the visual inspection of the image, an empty aluminum package was observed, excessive wrinkling and a hole that appeared to be caused from the outside was noted on the sheet of the product.As part of our quality process, the manufacturing records for this lot serial number were reviewed and manufacturing standards were met prior to the release of this lot.Additional monitoring of complaint information for potential safety signals will be conducted through complaint trends as part of post-market surveillance.

Event Description

It was reported that a patient underwent an unknown procedure on an unknown date in 2022 and the mesh was used.It was reported that when opening the device, the package, which assured the sterility, presented a hole while the cardboard package was intact and not unsealed.It was reported that the device could not be used.It was also reported that the device was not used on the patient.It was reported that another device had been used.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 04/27/2022.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.Additional information:  d9, h3, h6 h3 evaluation: one opened foil, of product was returned for evaluation.Upon visual inspection of the returned sample, the foil was inspected and multiples holes in the cavity and excessive wrinkles were 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 is conducted through complaint trending as part of post-market surveillance.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 06/08/2022.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.Additional h3 evaluation: one opened foil of product code was returned for evaluation.Upon visual inspection of the returned sample, the foil was inspected and multiples holes in the cavity and excessive wrinkles were noted.A possible cause for these conditions is due to improper handling during transit or storage.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.

• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-CORNELIA; 655 ethicon circle; cornelia GA 30531
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13728370
• MDR Text Key: 287015968
• Report Number: 2210968-2022-01704
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031047723
• UDI-Public: 10705031047723
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K060713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: PCDH1
• Device Catalogue Number: PCDH1
• Device Lot Number: QMBCWBZ0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1