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

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

Patient Problems Wound Dehiscence (1154); Hematoma (1884); Unspecified Infection (1930); Necrosis (1971)

Event Date 12/12/2021

Event Type  Injury  

Event Description

Title: teaching microsurgical breast reconstruction-a retrospective cohort study.The aim of this study was to present an approach for teaching deep inferior epigastric artery perforator (diep) and transverse upper gracilis (tug) flap breast reconstruction, which can diminish early complications and provide secure and satisfying outcomes from the first breast reconstruction with diep or tmg flap, respectively.A total of 95 patients participated in diep and 93 patients participated in tug flaps were included into this study.Once the flap was elevated, the same team inset the flap and performed the arterial anastomosis with the use of interrupted sutures (8-0 ethilon, ethicon inc., sommerville, nj, usa).Postoperative flap monitoring consisted of capillary refill assessment every hour for 5 days.Importantly, the same operative technique and postoperative protocol for flap monitoring and anticoagulation was utilized in all cases.The reported complication included fat necrosis (n=15) treatment: not mentioned, wound dehiscence (n=6) treatment: not mentioned, infection(n=5) treatment: not mentioned, hematoma(n=12) treatment: not mentioned.In conclusion, the introduced stepwise training approach is a safe and effective method for teaching microsurgical breast reconstruction with means of diep and tug flaps.Importantly, prior to starting microsurgical breast reconstruction training, trainees must be confident with general breast surgery and microsurgery.

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: https://doi.Org/10.3390/jcm10245875.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• 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: 18323266
• MDR Text Key: 330428825
• Report Number: 2210968-2023-09746
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NA
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2023
• 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: 11/27/2023
• 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): Other