MAUDE Adverse Event Report: ETHICON INC. MCRYL+ VIO 36IN 4-0 S/A FS-2; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	MCP922H
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).To date, the device has not been returned.If the product is returned for evaluation, any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Event or Problem Description
It was reported by a veterinarian that an animal underwent a dental extraction procedure on (b)(6) 2019 and suture was used.Post operatively, while the patient was still in the hospital but recovered, the patient experienced bleeding from the mouth.The suture had come undone and was not present.The patient was treated with pressure and silver nitrate to control bleeding.
Additional Manufacturer Narrative
(b)(4).A manufacturing record evaluation was performed for the finished device mkm284 number, and no non-conformance's were identified.

• Brand Name: MCRYL+ VIO 36IN 4-0 S/A FS-2
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8528449
• Report Number: 2210968-2019-80492
• Device Sequence Number: 16740257
• Product Code: GAM
• UDI-Device Identifier: 10705031046726
• UDI-Public: 10705031046726
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K050845
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2019

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: No Information
• Device Expiration Date: 08/31/2020
• Device Catalogue Number: MCP922H
• Device Lot Number: MKM284
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 05/03/2019
• Initial Report FDA Received Date: 04/18/2019
• Supplement Report FDA Received Date: 05/08/2019
• Patient Sequence Number: 1