BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NYLON SUTURE UNKNOWN PRODUCT

    MDR report key: 7403172 · Received April 6, 2018

    Report

    Report Number
    2210968-2018-71971
    Event Type
    Injury
    Date Received
    April 6, 2018
    Report Date
    March 19, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAR
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (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)

    Description of Event or Problem · 1

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246712 NYLON SUTURE UNKNOWN PRODUCT SUTURE, NON-ABSORBABLE, SYNTHETIC GAR ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Required Intervention