MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO HERNIA SYSTEM 7.5CM UNDERLAY; MESH, SURGICAL, POLYMERIC

Model Number UHSM

Device Problems Delivered as Unsterile Product (1421); Difficult to Open or Remove Packaging Material (2922)

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

Event Date 01/01/2022

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.The product upon which this medwatch is based has been received, however, the product evaluation is not yet complete.Any further information derived from the evaluation will be submitted in a supplemental 3500a form.Additional information was requested and the following was obtained: please provide procedure name and date.Please confirm the product code of the device presenting the alleged issue.Two lot numbers were provided (rlbbgmc0/rlbbhmc0), please clarify which is the lot number of the product involved in this issue? it is stated that the device was "rendered un-sterile".Please clarify if the device was received with any hole, tear or puncture, any open or incomplete seal that compromised sterility.Or/ was sterility compromised after manipulating the package trying while trying to open it? when i entered information on the form the wrong (upa37615) product code was captured.The correct code and product that should have been replaced is uhsm (lot rlbbhmco) please replace one each of the code uhsm.

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 by that during the unknown procedure, the box packaging was nearly impossible to open and finally rendered the device un-sterile.There were no adverse patient consequences reported.Additional information was requested.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 05/31/2022.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.H3 evaluation: the product was returned for evaluation.Visual inspection evaluation was conducted on the returned device.Visual analysis of the returned sample determined that one opened foil packet of product was received for evaluation, the foil was observed opened and damaged (tear) due to handling.The condition of the sample received indicates improper handling of the device.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.Product complaint # (b)(4).Date sent to the fda: 05/31/2022.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 HERNIA SYSTEM 7.5CM UNDERLAY
• 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
• MDR Report Key: 14179206
• MDR Text Key: 289897714
• Report Number: 2210968-2022-02856
• Device Sequence Number: 1
• Product Code: FTL
• UDI-Device Identifier: 10705031132467
• UDI-Public: 10705031132467
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: UHSM
• Device Catalogue Number: UHSM
• Device Lot Number: RLBBHMC0
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1