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	No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
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, and no non-conformances were identified.To date the device has not been returned.If the device or further details are received at the later date a supplemental medwatch will be sent.The following information was requested, but unavailable: what date did the patient present with symptoms? did the operating surgeon observe any suture deficiency or anomaly before, during, after the suture placement or during any re-operation? what was the date of the second procedure? can you describe the appearance of the suture during the second procedure? was there any precipitating stress factor for the sutures untying, breakage or pulling out of the tissue?.
Event or Problem Description
It was reported that the cat underwent an ovariectomy procedure in (b)(6) 2019 and suture was used.Less than five days post op the animal presented with an inflammatory reaction and eventration.The overlock of the muscular wall with suture was ruptured.
Additional Manufacturer Narrative
Date sent to the fda: 3/25/2020.Corrected h-6 patient codes: 2199.

• 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: 9831663
• Report Number: 2210968-2020-02054
• Device Sequence Number: 2929519
• 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,Followup
• 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
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 03/13/2020
• Supplement Report FDA Received Date: 03/25/2020
• Patient Sequence Number: 1