BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HISTOACRYL FLEXIBLE PACK 5

    MDR report key: 9401831 · Received December 3, 2019

    Report

    Report Number
    3003639970-2019-00854
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    B.BRAUN SURGICAL SA
    Product Code
    MPN
    PMA / PMN Number
    SEE H10
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510K: 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. K140243. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPLICATION CHIPS WERE EMPTY. THE REPORTER INDICATED THAT WHEN THE PACKAGE WAS OPENED, THERE WERE NO APPLICATION CHIPS (1050079).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1200305 HISTOACRYL FLEXIBLE PACK 5 TISSUE ADHESIVES MPN B.BRAUN SURGICAL SA 1051250P 219335N2

    Patients

    Seq Age Sex Outcome Treatment
    1