MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO ADVANCED; MESH, SURGICAL, POLYMERIC

Model Number UPA31015

Device Problem Delivered as Unsterile Product (1421)

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

Event Date 01/01/2021

Event Type  malfunction  

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: one unopened sample of product was returned for evaluation.Upon visual inspection of the returned sample, the foil was inspected and multiples holes in the cavity and were noted.In addition, the foil was observed with marks that appears to be caused by a pen.Due to the damages found on the device, 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.Additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post-market surveillance.Additional information was requested and the following was obtained: please explain in detail how was the primary package defective? was there any hole, tear, or puncture that compromises sterility? any open or incomplete seal? foil packaging of mesh shows a series of punctiform indentations.It is unclear, whether the foil actually perforated.Please clarify if there were any adverse patient consequences due to this event? if yes, please explain in detail: issue was detected pre op, therefore no harm to patient how was procedure successfully completed? with new mesh.Please provide status of product return: product is in transit to loc.

Event Description

It was reported that a patient underwent a hernia repair on an unknown date in 2021 and the mesh was used.Prior to surgery, it was found that the primary packaging was defective.It was reported that the foil packaging of the mesh showed a series of punctiform indentations, but it was unclear whether the foil actually perforated.A like device was used to successfully complete the procedure.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 05/17/2022.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 was provided for h3 evaluation: one unopened sample of product was returned for evaluation.Upon visual inspection of the returned sample, the foil was inspected and multiples holes were noted and the sterile barrier was compromised.The packaging was opened to confirm that the holes were noted to be from the outside in causing sterility breach.In addition, the foil was observed with marks that appear to be caused by a pen.Due to the damages found on the device, the complaint is confirmed, that 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.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 11/11/2022.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.

• Brand Name: ULTRAPRO ADVANCED
• 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 D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 12740915
• MDR Text Key: 284970605
• Report Number: 2210968-2021-10660
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031236998
• UDI-Public: 10705031236998
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K070224
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: UPA31015
• Device Catalogue Number: UPA31015
• Device Lot Number: QLBCDKD0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1