MAUDE Adverse Event Report: ETHICON INC. PROLENE SUTURE 18"(45CM) 5-0 BLU; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number	8681G
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Not Applicable (3189)
Date of Event	06/11/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).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.Additional information was requested and the following was obtained: what was the name of the procedure? scar revision left forearm.What was the date of the procedure? (b)(6) 2018.What tissue was the prolene suture used on? left forearm skin.What was the condition of the tissue the prolene suture was used on? normal skin.Was there any patient predisposing event (cough, fall, etc) prior to dehiscence? no, felt a pop when closing the car door.What post op date did the patient return with dehiscence? same day.What are the patient age, weight and bmi, past medical history? (b)(6) female, (b)(6).What is the surgeon opinion of the contributing factors to the dehiscence? not sure, suture broke mid substance, not at the know where a running suture tends to dehisce.What is current status of the patient? healing fine.
Event or Problem Description
It was reported that a patient underwent scar revision procedure on (b)(6) 2018 and continuous suture was used to close the wound.Later the same day, the patient reported a pop after closing a car door.The patient experienced dehiscence of the wound.An additional procedure was performed and the surgeon confirmed the suture was broken post op along the suture line (not at the knot).It was reported that the patient is healing fine.Additional information was requested.
Additional Manufacturer Narrative
(b)(4).The device history records were reviewed and the manufacturing criteria were met prior to the release of this lot.

• Brand Name: PROLENE SUTURE 18"(45CM) 5-0 BLU
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 7685048
• Report Number: 2210968-2018-74329
• Device Sequence Number: 11091910
• Product Code: GAW
• UDI-Device Identifier: 10705031018853
• UDI-Public: 10705031018853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133356
• 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): 06/20/2018

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 Expiration Date: 07/31/2022
• Device Catalogue Number: 8681G
• Device Lot Number: LJJ636
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2018
• Supplement Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 07/18/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR
• Patient Weight: 57