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

Model Number UHSM

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 11/19/2021

Event Type  malfunction  

Manufacturer Narrative

Product complaint # (b)(4).A photo of 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: hernia repair 11/19.Please provide lot number: lot qbbdmgb0.Please clarify if there were any adverse patient consequences due to this event? none, device was not used on the patient.How was procedure successfully completed? another mesh of the correct size was used to complete the procedure.Is the package available for analysis? no facility threw it away.Are there any photos for visual analysis? yes, rep has pictures and will send them.The foil packaging that the mesh is in did not display the dimensions of the mesh.None of the individual packaging displays the size.Facility mentioned every mesh listed on our website has the same dimension in error as there are multiple sizes of mesh available.

Event Description

It was reported that a patient underwent a hernia repair on (b)(6) 2021 and the mesh was used.During surgery, there was an inability to discern the correct size of the device because of poorly labeled packaging.The wrong size was retrieved and had to be discarded.A like device was used to 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: 12/19/2021.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.The doctor requested a mesh but didn¿t know what size they were other than medium and large as there are no measurements on the package.The doctor ended up wasting one because it was too small.Additional information was requested and the following was obtained: if possible, can you resend these photos as they are blurry and the investigation team cannot perform an evaluation with what is provided? the issue is not with the images sent but rather the current packaging and the fact that mesh sizes are not present on the packaging.

Manufacturer Narrative

Product complaint # (b)(4).Date sent to the fda: 02/15/2022.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: as per visual analysis of image received for evaluation, a foil package of product could be observed, the mesh and the printing information is not clear to determine the reported condition in the picture.The code is distributed in sizes small, medium and large.The code uhsm (medium).As part of our quality process, manufacturing records were reviewed for this lot's serial number and manufacturing standards were met prior to the release of this lot.No conclusion could be reached as the sample was not returned for analysis.Additional complaint information is tracked for potential safety signals through complaint trends as part of post-market surveillance.

• 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 D2284 1; GM D22841
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869
• MDR Report Key: 13023486
• MDR Text Key: 287249331
• Report Number: 2210968-2021-12676
• 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,Followup
• Report Date: 12/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: UHSM
• Device Catalogue Number: UHSM
• Device Lot Number: QBBDMGB0
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization