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

Catalog Number	MCP922H
Medical Device Problem Codes	Break (1069); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Unspecified Infection (1930); No Code Available (3191)
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.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.
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.It was reported that the suture has possibly not held because of the knots coming undone.It was reported that several days post op on (b)(6) 2019 , the animal experienced dehiscence and bleeding from the mouth.The sutures were infected and some were missing.The patient was treated with antibiotics and healed by secondary intention.Post-op directions were followed.
Additional Manufacturer Narrative
Product complaint # (b)(4).Corrected: evaluation code- 3191 - knots untying post op.

• 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: 8525613
• Report Number: 2210968-2019-80482
• Device Sequence Number: 1883777
• 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,health profession
• 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: 03/22/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 04/18/2019
• Patient Sequence Number: 1