MAUDE Adverse Event Report: ETHICON INC. NYLON SUTURE UNKNOWN PRODUCT; SUTURE, NON-ABSORBABLE, SYNTHETIC

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Erythema (1840); Scar Tissue (2060)

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.Additional information was requested and the following was obtained: were the cases discussed in this article previously reported to ethicon? -no.If yes, please provide a complaint reference number.Does the surgeon believe that any deficiency of the ethicon product pds suture caused and/or contributed to the adverse events described in the article?- no information.Citation: prs global open.2017.Doi: 10.1097/gox.0000000000001278.(b)(4).

Event Description

It was reported in journal article title: s-shaped wound closure technique for dumbbell-shaped keloids authors: seiji komatsu, md, phd, shougo azumi, md, yuko hayashi, md, tsuneharu morito, md, yoshihiro kimata, md, phd citation: prs global open.2017.Doi: 10.1097/gox.0000000000001278.The authors reported that surgical excision with post-operative radiation therapy is considered one of the most efficacious treatments for keloid management.A total of 5 patients (3 men and 2 women; age range: 22 to 50 years old) with 8 lesions underwent the procedure and were included in the study.During the surgical procedure, all keloids were extralesionally excised above the deeper fascia under local anesthesia.The incision was closed by applying deep fascial sutures using pds ii 3-0 sutures, subcutaneous sutures using pds ii 3-0 or 4-0, and superficial sutures using nylon 6-0.Reported complications included a (b)(6) patients with temporary erythema and mild elevation of the scar tissue, 7 and 10 months post-operatively which were treated with corticosteroid tape and quickly flattened and turned white.It was concluded that the s-shaped wound closure technique for dumbbell-shaped keloids made it possible to avoid additional incision or excision of normal skin and form non-straight scars.Although this procedure has limited application, it is a simple and useful option for keloid treatment.

• Brand Name: NYLON SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, NON-ABSORBABLE, SYNTHETIC
• 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: 7403172
• MDR Text Key: 104671803
• Report Number: 2210968-2018-71971
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946173
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• 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
• Patient Age: 25 YR