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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Post Operative Wound Infection (2446)

Event Date 07/26/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by ethicon inc, or its employees that the report constitutes an admission that the product, ethicon inc, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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.Does the surgeon believe that any of the ethicon products involved caused and/or contributed to the post-operative complications described in the article? which specific ethicon products have been used during the procedures (product code, lot number)? does the surgeon believe there was any deficiency with any of the ethicon products used in this procedure? if so, please provide details.Were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number.Patient demographics? this report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.H6 component code: g07002 ¿ device not returned.The single complaint was reported with multiple events.There are no additional details regarding the additional events.Citation: emerg med j 2022;39:650¿654.Https://doi.Org/10.1136/emermed-2021-211540.Related events captured via 2210968-2023-09507 and 2210968-2023-09508.

Event Description

Title: non-sterile gloves and dressing versus sterile gloves, dressings and drapes for suturing of traumatic wounds in the emergency department: a non-inferiority multicentre randomised controlled trial the aim of this multicentre single-blinded randomised controlled study was to compare the rate of wound infection after suturing traumatic lacerations with non-sterile gloves and dressings versus sterile gloves, dressings and drapes in the ed.Between july 25, 2012 to december 31, 2016, a total of 1480 patients who presented to the ed with a traumatic wound for which sutures were required were included in the study.The se patients were randomized in the sterile (n=747) or non-sterile (n=733) study group.The mean age in the sterile versus non-sterile group was 39.2 and 39.5 years.Most patients were male (sterile group: 74.2%; non-sterile group: 73.0%).Materials used in both protocols included: chlorhexidine for disinfection, lidocaine 1% for infiltration anaesthesia, sterile sutures (ethilon nylon suture size 3.0 up to 6.0 and vicryl 3.0 up to 5.0) and sterile instruments.The study procedures differed between groups in the use of sterile versus non-sterile dressings and gauzes, sterile surgical gloves versus non-sterile boxed gloves and the use of sterile (fenestrated) drapes in the sterile protocol only.Reported complications include wound infection (n=?).In conclusion, although recruitment ceased prior to reaching our planned sample size, the findings suggest that there is unlikely to be a large difference between the non-sterile gloves and dressings for suturing of traumatic wounds and sterile gloves, dressings and drapes for suturing of traumatic wounds in the ed.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 18274018
• MDR Text Key: 329830984
• Report Number: 2210968-2023-09507
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• 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: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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