MAUDE Adverse Event Report: ETHICON INC. ETHILON BLUE 2.0M 75CM W/NDL; SUTURE, NONABSORBABLE, SYNTHETIC

Catalog Number W1685T

Device Problem Loss of or Failure to Bond (1068)

Patient Problems Wound Dehiscence (1154); Not Applicable (3189)

Event Type  Injury  

Manufacturer Narrative

(b)(6).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: you reported qty of 24, did you mean 24 sutures in the box? yes.What was the issue with the suture? there was dehiscence of the wound.How many patients experienced wound dehiscence? don¿t know.What are the patient age, weight, gender, past medical history? don¿t know.What was the date of the procedure? don¿t know.What was the name of the procedure? ortopedic.What tissue layer was the suture placed in? in the skin.How was the suture placed (continuous or interrupted)? don¿t know.Was there any patient event (fall, exercise, cough) prior to the dehiscence? no.What post op day did the patient present with dehiscence? 2/ 3 day.What was the date of the second procedure for re-suturing? don¿t t know.Can you describe the appearance of the suture during the second procedure? no.Can you identify the lot number? no.What is the current condition of the patient? don¿t know.

Event Description

It was reported that a patient underwent orthopedic procedure on unknown date in (b)(6) 2017 and suture was used on the skin.Approximately two to three days post op, the patient experienced wound dehiscence.A second procedure was performed on an unknown date to close the wound.Additional information has been requested.

• Brand Name: ETHILON BLUE 2.0M 75CM W/NDL
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7671244
• MDR Text Key: 113520668
• Report Number: 2210968-2018-74191
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: W1685T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention