BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFIL VIOLET 8/0 (0.4) 30CM 2XDLM6

    MDR report key: 8879018 · Received August 9, 2019

    Report

    Report Number
    3003639970-2019-00608
    Event Type
    Malfunction
    Date Received
    August 9, 2019
    Report Date
    August 9, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    GAM
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED DEVICE NOT MARKETED IN THE U.S., HOWEVER, SIMILAR DEVICES OR DEVICES THAT SHARE COMPONENTS, RAW MATERIALS, PROCESS METHODS OR OTHER TECHNOLOGICAL CHARACTERISTICS ARE REGISTERED WITHIN THE U.S. K031286. WHEN ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TWO PACKS OF #1048610 IN BOX. THE REPORTER INDICATED THAT THE TWO ITEMS IN BOX DO NOT MATCH THE OUTER LABEL. WHEN OPENING THE OUTER BOX OF CODE G1048702, IT WAS FOUND THAT TWO PACKAGES OF CODE 1048610 WERE ALSO IN THE BOX.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    675323 SAFIL VIOLET 8/0 (0.4) 30CM 2XDLM6 SYNTHETIC ABSORBABLE BRAIDED S GAM B.BRAUN SURGICAL SA G1048702 117385

    Patients

    Seq Age Sex Outcome Treatment
    1