BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILK SUTURE UNKNOWN PRODUCT

    MDR report key: 7039448 · Received November 16, 2017

    Report

    Report Number
    2210968-2017-71286
    Event Type
    Injury
    Date Received
    November 16, 2017
    Date of Event
    August 31, 2016
    Report Date
    November 29, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAP
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE &AESTHETIC SURGERY (2017)70, 392-400; HTTP://DX.DOI.ORG/10.1016/J.BJPS.2016.08.022.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # ==> PC-000066171 ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT VICRYL PLUS SUTURE. SILK SUTURE AND ETHILON SUTURE CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. IS THE PRODUCT CODE AND LOT NUMBER AVAILABLE FOR ANY OF THE ETHICON DEVICES USED? NO FURTHER INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE "UPPER LIP LIFT WITH A ¿T¿-SHAPED RESECTION OF THE ORBICULARIS ORIS MUSCLE FOR ASIAN PERIORAL REJUVENATION: A REPORT OF 84 PATIENTS¿ PATIENTS UNDERWENT SURGERY FOR UPPER LIP LIFT FROM 2012 TO 2014 AND SUTURE WAS USED. SKIN EXCISION HEIGHT WAS DESIGNED ON THE BASIS OF THE GOLDEN PROPORTION OF THE LOWER REGION OF THE FACE. THE INCISION WAS MADE AT THE SUBNASAL (INFERIOR BORDER OF THE COLUMELLA-NOSTRIL-ALAR) REGION. THE FLAPS WERE SUTURED TO THE CAUDAL SEPTUM CARTILAGE WITH SUTURE. THE PATIENTS RECEIVED INTERMITTENT PERIODS OF ICE COMPRESSION WITHIN 3 DAYS FOLLOWING SURGERY, AND SUTURES WERE REMOVED 5 DAYS POST OPERATION. RETROSPECTIVE FOLLOW-UP WAS PERFORMED AT 1 WEEK, 1 MONTH, AND 3-24 MONTHS POSTOPERATION. PATIENT WITH INCISION SCAR MAY HAVE RECEIVED NONSURGICAL TREATMENT, INCLUDING SCAR INJECTION OF STEROIDS OR CO2 LASER TREATMENT, OR SURGICAL SCAR RESECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    817923 SILK SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SILK GAP ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention