MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 3-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP452H
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an animal underwent an oophorectomy veterinary procedure in (b)(6) 2025 and suture was used.Post-op, problem: abdominal incisional wound dehiscences with eventration during oophorectomy, the veterinarian uses vicryl plus vcp452h for ovarian pedicle ligation, muscle wall overshot and skin overshot.Cats and rabbits wear a collar post-operatively.During (b)(6) 2025, a cat and a rabbit were reviewed 24h to 48h days after oophorectomy (exact dates unknown), for abdominal incisional wound dehiscence with eventration.In both cases, the vicryl plus vcp452h of the abdominal wall overjet had ruptured in length, with the overjet start and end points present.The dehiscences were surgically repeated, using another vicryl (exact reference not known); the scar evolution was then normal for the rabbit; it is ongoing for the cat.The veterinarian suspects an abnormality on a lot of threads of vicryl plus vcp452h.Additional information was requested.
Additional Manufacturer Narrative
Product complaint # (b)(4) h6.Component code: g07002 - device not returned.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.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.(b)(4): abdominal incisional wound dehiscences in a cat with eventration.(b)(4): abdominal incisional wound dehiscences in a rabbit with eventration.It was reported that "the dehiscences were surgically repeated", could you kindly provide the lot number of these devices that demonstrated the alleged deficiency, please? could you kindly perform and document the follow-up attempt for the product return? furthermore, please ensure that the shipment tracking number is recorded in the notes or rmao sections.Please provide the source or name of person providing answers to follow-up questions: additional information received: the dehiscences were surgically repeated, the dehiscences were repaired surgically, d4: udi: the expiration date is currently not available.Therefore, the full udi is currently not available.
Additional Manufacturer Narrative
Product complaint # (b)(4) date sent to the fda: 7/22/2025.This report is being submitted pursuant to the provisions of 21 cfr, part 803, part 4 subpart b.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, 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: d4, h4, h6 a manufacturing record evaluation was performed for the finished device lot, and no non-conformances were identified.

• Brand Name: VCL+ VIO 27IN 3-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• 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: orla o'mahony ; 1000 route 202; raritan, NJ 08869 ; 3035526892
• MDR Report Key: 22298686
• Report Number: 2210968-2025-07158
• Device Sequence Number: 15764068
• Product Code: GAM
• UDI-Device Identifier: 10705031149977
• UDI-Public: (01)10705031149977(17)270731(10)UJBBGXA0
• Combination Product (Y/N): Y
• Initial Reporter Country: FR
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VCP452H
• Device Lot Number: UJBBGXA0
• 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: 05/22/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/02/2024
• 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
• Patient Sex: Unknown