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 Problems Eye Injury (1845); Insufficient Information (4580)

Event Date 05/16/2023

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.An attempt has been 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.Related events captured via 2210968-2024-02041, 2210968-2024-02042, 2210968-2024-02043 and 2210968-2024-02044.Citation: aesth plast surg (2023) 47:1430¿1438.Https://doi.Org/10.1007/s00266-023-03382-3.

Event Description

Title: modified levator resection technique for moderate congenital blepharoptosis.The objective of this study is to solve the above problems, our team have made modifications to the levator resection technique in three aspects: releasing the levator muscle sufficiently, preserving the supporting structure of the conjunctiva, and placing multiple suture sites.Between january of 2020 to april of 2022, a total of 57 patients (81 eyes) underwent levator resection.There were 20 men and 37 women.The age ranged from 18 to 39 years, with an average of 24.2 ± 4.6 years.A total of 3 patients were dissatisfied with the final result, of which 2 patients underwent reoperation.One was attributable to overcorrection, poor eyelid closure function, and asymmetrical upper eyelid margin level.The other was attributable to undercorrection and asymmetrical upper eyelid margin level.Finally, satisfactory correction result, eyelid closure function, and symmetry were obtained by adjusting the level where the suture passed through the levator muscle.One patient (2 eyes) who showed undercorrection was satisfied with the eyelid symmetry because the mrd1 difference between both eyes was less than 1 mm; thus, further surgical treatment was not required.The first firm bite was taken approximately 1 mm below the intersection of the midpupil line and the upper border of the tarsus with a round-body needle prolene 5¿0 suture (ethicon).The needle passed through the levator muscle and then passed back approximately 2 mm lateral to the entry point of the suture.The suture was then tied.To create a secure and crisp upper eyelid crease, a series of 7 to 9 stitches from the dermis to the distal edge of the levator (7¿0 vicryl; ethicon) were performed and then rein-forced with the final skin-levator-skin closure with interrupted ethilon 7¿0 sutures (ethicon).A frost suture (3¿0 silk) was placed in the lower eyelid to close the palpebral fissure at night.This suture was removed on postoperative day 7, and its function was replaced by breathable paper tape.Reported complications include attributable to overcorrection (n=1), poor eyelid closure function (n=1), asymmetrical upper eyelid margin level (n=1); undercorrection and asymmetrical upper eyelid margin level (n=1).In conclusion, this modified levator resection technique introduced in this study is effective in correcting moderate congenital blepharoptosis, while minimizing rl, undercorrection, conjunctival prolapse, eyelid contour abnormality by releasing the levator muscle sufficiently, preserving the supporting structure of the conjunctiva, and placing multiple suture sites.

• 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: 18794097
• MDR Text Key: 336394789
• Report Number: 2210968-2024-02044
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• 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