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 Hematoma (1884); Unspecified Infection (1930); Necrosis (1971); Paralysis (1997); Scar Tissue (2060); Seroma (2069); Numbness (2415)

Event Date 10/27/2021

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.(b)(4).The single complaint was reported with multiple events.There are no additional details regarding the additional events.Related events captured via 2210968-2023-00001, 2210968-2023-00002, 2210968-2023-00003, and 2210968-2023-00005.Citation: current otorhinolaryngology reports (2021) 9:457¿466 https://doi.Org/10.1007/s40136-021-00373-3.

Event Description

Title: nuances of facelifting for the male patient.In the preoperative holding area, the markings are made with surgical pen for rhytidectomy and any additional procedures.The preauricular marking starts in the temporal tuft above the zygomatic root then drawn to the superior helical insertion.The marking then follows a post-tragal course unless a preauricular incision is planned.If a preauricular incision is planned, the incision is gently curved in the preauricular area into a preexisting crease.The incision should not be entirely straight, rather a distance away from the incisura and in front of the tragus.One must leave a portion of non-hair bearing skin when moving the hair bearing skin posteriorly and superiorly.The clamped redundancy is then cauterized, cut, and sutured with a 3¿0 vicryl® & supplemented with 3¿0 mersilene ® (ethicon, somerville, nj, usa) in male patients.Additional 3¿0 monocryl (ethicon) sutures are used to further support the smas flap anteriorly and posteriorly and smooth the edges.5¿0 ethilon (ethicon) sutures are placed to realign the skin.The non-hair bearing skin of the preauricular and postauricular skin flaps are then closed with 5¿0 plain gut (ethicon) suture in running, locking fashion.Reported complications included hemaotoma, seroma, infection,scarring , flap necrosis , facial paralysis and numbness in conclusion rhytidectomy in male patients is becoming increasingly popular as there is less stigma regarding aesthetic surgery and patients want to obtain a more natural, refreshed appearance.With male patients, proper patient selection is as important as preoperative counseling on achievable results.Rhytidectomy techniques remain similar in both male and female patients, but with various technical modifications, namely, incision planning, trichophytic incisions, and avoiding placing hair-bearing skin in unnatural locations.Additionally, there are complications such as hematoma that occur in males more than females, but these can often be mitigated with proper preoperative medical optimization as well as use of tranexamic acid and blood pressure control during surgery.Overall familiarity with surgical principles and facial and neck anatomy should avoid complications, ensure good outcomes, and result in patient satisfaction.

• 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: 16086381
• MDR Text Key: 306528536
• Report Number: 2210968-2023-00004
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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: 12/20/2022
• 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