MAUDE Adverse Event Report: ETHICON INC. VCL+ VIO 27IN 2-0 S/A FS-1; SUTURE, ABSORBABLE, SYNTHETIC

Model Number	VCP453H
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Inflammation (1932)
Date of Event	12/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device vcp453h; pebcxgs0 number, and no non-conformances were identified.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.
Event or Problem Description
It was reported that the cat underwent an ovariectomy procedure and suture was used.Less than 5 days after the surgery, the cat presented with an inflammatory reaction and a eventration.Post op the suture broke.There were no patient consequences reported.

• Brand Name: VCL+ VIO 27IN 2-0 S/A FS-1
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876
• MDR Report Key: 9826439
• Report Number: 2210968-2020-01997
• Device Sequence Number: 1431909
• Product Code: GAM
• UDI-Device Identifier: 10705031053366
• UDI-Public: 10705031053366
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/19/2020

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 Expiration Date: 04/30/2022
• Device Model Number: VCP453H
• Device Catalogue Number: VCP453H
• Device Lot Number: PEBCXGS0
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2020
• Initial Report FDA Received Date: 03/12/2020
• Patient Sequence Number: 1