MAUDE Adverse Event Report: ETHICON INC. VICRYL PLUS SUTURE 27"(70CM) 3-0 UND; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	VCP458H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The actual device batch number associated with this event is not known.The possible batch number is reported as follows: batch mgk774, manufacture date: 06/26/2018, expiration date: 05/31/2023.The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.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.
Event or Problem Description
It was reported that patient underwent tka on unknown date and suture was used.Around 2 weeks after the procedure, the patient experienced infection.The doctor commented that treatment for infection was done, but detail is unknown.The current patient status is unknown.Additional information will be requested.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Additional information was requested and the following was obtained: please clarify the surgeon opinion that the infection was not related to the dermabond prineo.The surgeon commented that there is no possibility that this event occurred due to the dermabond.What is the physician¿s opinion of the contributing factors to the infection? there was a possibility that the suture was infected.Is the product or representative sample (product from the same lot number) available for evaluation? no sample will be returned.

• Brand Name: VICRYL PLUS SUTURE 27"(70CM) 3-0 UND
• 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: 8042617
• Report Number: 2210968-2018-76970
• Device Sequence Number: 19158219
• Product Code: GAM
• UDI-Device Identifier: 10705031053373
• UDI-Public: 10705031053373
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K032420
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: VCP458H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/11/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 11/06/2018
• Supplement Report FDA Received Date: 11/30/2018
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DERMABOND PRINEO
• Outcome Attributed to Adverse Event: Required Intervention