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U.S. Department of Health and Human Services

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

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ETHICON INC. ETHILON NYLON SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE Back to Search Results
Catalog Number ETHILONUNK
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Edema (1820); Hematoma (1884); Unspecified Infection (1930); Scarring (2061); Seroma (2069); Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative

(b)(4). Multiple device issues captured in the associated reports 2210968-2020-02272, 2210968-2020-02273. 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. The single complaint was reported with multiple events. There are no additional details regarding the additional events. Citation: prs global open (2019); doi: 10. 1097/gox. 0000000000002575. Additional information was requested and the following was obtained: does the surgeon believe that ethicon products (mersilened suture and vicryl suture and ethilon sutures) involved caused and/or contributed to the post-operative complications (hematoma, extrusion, nerve injury, scar, infection, seroma, dehiscence) described in the article? does the surgeon believe there was any deficiency with the ethicon products (mersilene suture and vicryl suture and ethilon suture) used in this procedure? were the cases discussed in this article previously reported to ethicon? if yes, please provide a complaint reference number. Patient demographics. The mersilene suture extrusion was due to suture being too superficial to skin. Mersilene sutures tend to extrude if placed below dermis. (b)(4).

 
Event Description

It was reported in a journal article with title: triple-c smas plication facelift for natural facial rejuvenation. This retrospective review aimed to present a novel, radially oriented, layered superficial musculoaponeurotic system (smas) plication: the triple-c smas plication which utilized customizable vectors in the pattern of a ¿c¿ to plicate the smas in 3 layers to lift and tighten the deep structures of the face. Between 09jan2017 and 08jan2018, a total of 110 consecutive patients (n=107 female [average age of 62. 1 years; average bmi of 23. 6 kg/m^2] and n=3 male [average age of 65 years; average bmi of 25. 8 kg/m^2]) underwent triple-c smas plication facelift for natural facial rejuvenation. The triple-c smas plication was performed in 3 layers. The first layer of the procedure was undertaken with 5-6 buried, interrupted 2-0 mersilene sutures and this involved the most aggressive smas plication. The second and third layers were performed with running, locking, horizontal mattress 2-0 vicryl sutures, and the suturing was continued until the soft tissues have been satisfactorily smoothed. The skin flap is inset with 4-0 vicryl sutures anteriorly and posteriorly. Incisions are then closed with 5-0 ethilon sutures in a running, locking fashion. The incision over the neck is closed with 4-0 vicryl sutures followed by running, locking 5-0 ethilon sutures. Complication s included major hematomas (n=2) requiring reoperation; minor hematomas (n=3) treated with aspiration; seromas (n=5); mild infection (n=1) treated with a course of oral antibiotics; neuropraxia involving zygomatic branch of the facial nerve (n=1) which resolved within 6 months with conservative management; postauricular epidermolysis in an area exceeding 2 cm^2 (n=2); hypertrophic scarring (n=12) treated with steroid and 5-fluorouracil injections; vicryl suture extrusion (n=3); dehiscence (n=2. 73%); prolonged edema (n=1. 82%); and contour irregularities (n=0. 91%). Revision facelift procedures (n=2) and scar revision (n=3. 63%) were performed during the study period. Traditional smas plication techniques involve single-layer, straight-line plications to lift the lower face and neck, limiting their versatility. The triple-c smas plication represents a novel technique to safely and effectively elevate the deep structures of the face in a radial pattern to restore a more youthful contour to the malar area, jawline, and neck. This represents a unique strategy for face lifting by which excellent results can be consistently obtained.

 
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Brand NameETHILON NYLON SUTURE UNKNOWN PRODUCT
Type of DeviceSUTURE, NONABSORBABLE
Manufacturer (Section D)
ETHICON INC.
p.o. box 151, route 22 west
somerville NJ 08876
Manufacturer (Section G)
ETHICON INC.
Manufacturer Contact
kara ditty-bovard
p.o. box 151, route 22 west
somerville, NJ 08876
6107428552
MDR Report Key9862781
MDR Text Key190126979
Report Number2210968-2020-02274
Device Sequence Number1
Product Code GAR
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL,LITERATUR
Reporter Occupation
Type of Report Initial
Report Date 02/26/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/20/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberETHILONUNK
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2020
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?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/20/2020 Patient Sequence Number: 1
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