MAUDE Adverse Event Report: ETHICON INC. PVP SMALL 4.3CM X 4.3CM; MESH, SURGICAL, POLYMERIC

Catalog Number PVPS

Device Problem Material Disintegration (1177)

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

Event Date 09/18/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an umbilical hernia procedure on (b)(6) 2023 and mesh was used.The surgeon reports that he opened a sterile package and while he was positioning it on the patient he saw that it had changed composition and lost its consistency.The patch has flaked off, requiring the surgeon to remove it from the patient.There was no delay due to the event and the procedure was successfully completed using a new product from the same batch.There were no adverse patient consequences.Additional information was requested.

Manufacturer Narrative

(b)(4).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 inc, 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 was requested and the following was obtained: - any patient consequences? no the device upon which this medwatch is based has been received, however, the evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.A review of the batch manufacturing records was conducted, and no related non-conformances were identified.

Manufacturer Narrative

(b)(4).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 inc, 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.H3 analysis summary: the product was returned to ethicon for evaluation.Visual inspection was conducted on the returned device.The returned samples determined that it was received, one opened sample that pertain to product code pvps.Upon visual assessment of the sample, it was observed that the mesh had damage caused by the degradation process.This condition caused the composition to change and lose its consistency.The foil was visually inspected, and wrinkles and holes in the cavity were observed.Due to the damages found on the packaging, a possible cause for this condition is due to improper handling during transit or storage.As part of the ethicon quality process, all devices are manufactured, inspected, and released to approved specifications.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.

• Brand Name: PVP SMALL 4.3CM X 4.3CM
• Type of Device: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-GMBH; robert-koch strasse 1; p.o. box 1409; norderstedt ; GM
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17914833
• MDR Text Key: 325467479
• Report Number: 2210968-2023-07649
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132412
• UDI-Public: 10705031132412
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K061533
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PVPS
• Device Lot Number: SEBCHSD0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1