BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GLYCOLON

    MDR report key: 17317566 · Received July 13, 2023

    Report

    Report Number
    9611459-2023-00002
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Report Date
    June 28, 2023
    Manufacturer
    RESORBA MEDICAL GMBH
    Product Code
    DZG
    PMA / PMN Number
    K143584
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    DENTIST
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE SURGEON'S INITIAL STATEMENT WAS AS FOLLOWS: "I HAVE BEEN USING GLYCOLON SUTURES IN ORAL SURGERY SINCE 2014. IN THE LAST 4 MONTHS THERE HAS BEEN AN INCREASE IN PREMATURE DISSOLUTION OF THE SUTURES AND PREMATURE OPENING OF THE WOUND EDGES WITH CLOSED FLAPS!". SURGEON FAMILIAR WITH THE DEVICE HAS HAD CASES OF PREMATURE SUTURE ABSORPTION RESULTING IN THE PREMATURE OPENING OF WOUND EDGES WITH CLOSED FLAPS. FURTHER INFORMATION HAS CONFIRMED THIS HAS AFFECTED PATIENTS IN 2 OPERATIONS. A SEPARATE REPORT HAS BEEN RAISED REGARDING THE OTHER OPERATION. THERE HAVE BEEN NO OTHER REPORTS OF THIS PREVIOUSLY FOR THIS DEVICE. FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2170622 GLYCOLON ABSORBABLE MONOFILAMENT SUTURE DZG RESORBA MEDICAL GMBH R00089726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| O