BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSYN

    MDR report key: 14498208 · Received May 25, 2022

    Report

    Report Number
    9612501-2022-00845
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 25, 2022
    Manufacturer
    DAVIS & GECK CARIBE LTD
    Product Code
    GAM
    UDI-DI
    10884521033214
    PMA / PMN Number
    K000037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ACCORDING TO THE REPORTER, AFTER OPENING THE PACKAGING FOR PREPARATION, THE NURSE SAW THAT THE SUTURE AND THE NEEDLE WERE DETACHED. A NEW SUTURE WAS USED INSTEAD. THERE WAS NOO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260989 BIOSYN SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC AC GAM DAVIS & GECK CARIBE LTD SM-691 D1G1889FY 10884521033214

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown