MAUDE Adverse Event Report: ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NONABSORBABLE, SYNTHETIC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930); Local Reaction (2035); Hernia (2240); Peritonitis (2252); Not Applicable (3189)

Event Date 01/21/2011

Event Type  Injury  

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.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Does the surgeon believe that the suture caused and/or contributed to the adverse events described in the article, specifically: infection and delayed wound healing? can you explain what is meant by delayed wound healing? what medical intervention was performed to treat the delayed wound healing? citation: coll.Antropol.2011;35(2): 439¿443.

Event Description

It was reported in journal article ¿efficacy of antimicrobial triclosan-coated polyglactin 910 (vicryl plus) suture for closure of the abdominal wall after colorectal surgery¿ that patients underwent elective colorectal surgery and suture was used to close the skin.The study compared abdominal wall healing in colorectal carcinoma patients from september 2008 to september 2009.Wound complications included inflammatory reactions to suture, wound infection and the patient required reoperation due to peritonitis, dehiscence requiring reoperation and incisional hernia.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville 08876-0151 ; 9082182792
• MDR Report Key: 7042412
• MDR Text Key: 92358871
• Report Number: 2210968-2017-71310
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention