BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN VLOC PRODUCT

    MDR report key: 4683964 · Received April 13, 2015

    Report

    Report Number
    1219930-2015-00299
    Event Type
    Injury
    Date Received
    April 13, 2015
    Report Date
    March 19, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). LITERATURE: CORTEZ, R. ET AL. BARBED SUTURES AND WOUND COMPLICATIONS IN PLASTIC SURGERY: AN ANALYSIS OF OUTCOMES. AESTHETIC SURGERY JOURNAL. 2015. VOL. 35(2)178-188. DOI: 10.1093/ASJ/SJU012.

    Description of Event or Problem · 1

    PROCEDURE: PLASTIC SURGERY. AS RECORDED IN THE LITERATURE REVIEWED, THE FOLLOWING FTR'S ARE LINKED BY ALLEGED COMPLICATION: (US201503-1252 AND -1451 THROUGH -1456) ADDITIONAL CASES RELATED TO THE SAME LITERATURE WITH DIFFERENT COMPLICATIONS CAN BE FOUND USING A SEARCH FOR THE ALTERNATE TRACKING NUMBER DOI 10.1093/ASJ/SJU012. ACCORDING TO THE AUTHOR: A RETROSPECTIVE REVIEW OF OUTCOMES IN VARIOUS PLASTIC SURGERY PROCEDURES WAS DONE TO DETERMINE WHETHER THE COMPLICATION RATES DIFFERED AFTER WOUND APPROXIMATION WHEN VARIOUS BRANDS OF BARBED VS NON-BARBED TRADITIONAL SUTURES WERE USED. IN THE V-LOC SUBSET, 7 (3.1%) OF 228 PATIENTS HAD NECROSIS AT THE WOUND SITE. CORTEZ, R. ET AL. BARBED SUTURES AND WOUND COMPLICATIONS IN PLASTIC SURGERY: AN ANALYSIS OF OUTCOMES. AESTHETIC SURGERY JOURNAL. 2015. VOL. 35(2)178-188. DOI: 10.1093/ASJ/SJU012. THIS REPORT IS FOR ONE OF SEVEN INCIDENTS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT HAS NOT BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245151 UNKNOWN VLOC PRODUCT VLOC SUTURE GAM COVIDIEN, FORMERLY US SURGICAL A DIVISON UNKNOWN-VLOC

    Patients

    Seq Age Sex Outcome Treatment
    1 Other