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 Edema (1820); Necrosis (1971)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Citation: eur j plast surg (1996) 19: 174; doi: https://doi.Org/10.1007/bf00176274.(b)(4).

Event Description

It was reported via journal article: "title : tensor fasciae lata myocutaneous flap reconstruction following ilioinguinal node dissection" author : d.N.Savant, a.V.Dalai, s.G.Patel, h.M.Bhathena, n.M.Kavarana citation: eur j plast surg (1996) 19: 174; doi: https://doi.Org/10.1007/bf00176274.The authors aimed to present their experience tensor fasciae latal (tfl) flap reconstruction following ilioinguinal node dissection.From jan1992 to jun1994, forty groin node dissection (gnd) were performed in 20 males and 5 females.The tensor fasciae lata (tfl) flap was used as an island in 35 cases and as a rotation flap in 5.In the procedure, the subcutaneous tissue in the lower edge of the skin incision is tacked down to the floor of the femoral triangle with 00 vicryl sutures.Fascia was tacked with 3-0 chromic catugut or vicryl to prevent shearing and loss of vascularity.The lap is sutured in two layers - vicryl for the subcutaneous tissue and 3-0 mersilk or ethilon for skin.Postoperatively, complications included varying degrees of flap necrosis (n=7) which were managed conservatively (n=4) or with split-skin grafting at a second stage(n=3), scrotal edema (n=3) and moderate to severe lymphedema of the lower limb (n=5).The tfl flap is a simple and reliable technique which for primary closure of defects after bilateral or unilateral gnd.

• Brand Name: ETHILON NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NONABSORBABLE
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• Manufacturer (Section G): ETHICON INC.
• Manufacturer Contact: darlene kyle ; p.o. box 151, route 22 west; somerville, NJ 08876-0151 ; 9082182792
• MDR Report Key: 7674321
• MDR Text Key: 113570003
• Report Number: 2210968-2018-74215
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• 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: 06/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention