MAUDE Adverse Event Report: ETHICON INC. ULTRAPRO* PART. ABSORB. MESH; MESH, SURGICAL, POLYMERIC

Catalog Number	UMM3
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erythema (1840); Inflammation (1932); Pain (1994); Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)
Date of Event	11/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint # (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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Please provide the patient's demographic information including age, gender, weight, bmi at the time of index procedure date and name of index surgical procedure? were any concomitant procedures performed? other relevant patient history/concomitant medications? please provide the onset date/time of the reaction from the initial procedure.Please describe any medical intervention required to treat the patient condition including medication name and results.Does the patient have a known allergic history to any medical devices, food and/or medication? was allergy testing performed? if so, please describe with results.Are there any photos available? what is the physician¿s opinion as to the etiology of or contributing factors to this event? what is the patient's current status? to date it has been reported that the device will not be returned.If the device or further details are received at a later date a supplemental medwatch will be sent.H6 component code: g07002 ¿ device not returned.
Event or Problem Description
It was reported that a patient underwent a tension free repair of inguinal hernia procedure (b)(6) 2024 and mesh was implanted.The patient experienced post-op inflammation and wound secretion.The patient was placed with patch during the surgery.After the surgery, the patient experienced incision pain, accompanied by redness and a small amount of exudate, suggesting a possible reaction to the patch.Administer medication therapy.Additional information has been requested.
Additional Manufacturer Narrative
Product complaint # (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 provided: date and name of index surgical procedure? tension-free repair of inguinal hernia in (b)(6) 2024.Were any concomitant procedures performed?--unk.Other relevant patient history/concomitant medications?--unk.Please provide the onset date/time of the reaction from the initial procedure.--(b)(6) 2024.Please describe any medical intervention required to treat the patient condition including medication name and results.--treat with medication, but details unknown does the patient have a known allergic history to any medical devices, food and/or medication?--unk.Was allergy testing performed? if so, please describe with results.--unk.Are there any photos available?--unk.What is the physician¿s opinion as to the etiology of or contributing factors to this event?-- related to product.What is the patient's current status?--unk.
Additional Manufacturer Narrative
Product complaint # (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.A manufacturing record evaluation was performed for the finished device lot number, and no related non-conformances were identified.

• Common Device Name: 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: 20860547
• Report Number: 2210968-2024-12925
• Device Sequence Number: 21049134
• Product Code: FTL
• UDI-Device Identifier: 10705031085886
• UDI-Public: (01)10705031085886(17)290228(10)TKBCLHA0
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K033337
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UMM3
• Device Lot Number: TKBCLHA0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 12/22/2024; 01/13/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/10/2025; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male