BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOBLAST BELLOWS

    MDR report key: 8781832 · Received July 11, 2019

    Report

    Report Number
    3007702492-2019-00002
    Event Type
    Injury
    Date Received
    July 11, 2019
    Report Date
    June 20, 2019
    Manufacturer
    BIOM'UP SA
    Product Code
    PMX
    UDI-DI
    03760193182705
    PMA / PMN Number
    P170012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BIOM'UP CONTACTED THE SURGEON THE DAY AFTER RECEIVING THE REPORT. THE SURGEON PROVIDED THE FOLLOWING FEEDBACK: THE AREA WAS DRY WHEN HE CLOSED. HE BELIEVES THE SURROUNDING TISSUE HAD ADHERED TOGETHER CLOSING OFF THE AREA IN WHICH THE HEMATOMA FORMED FROM THE DRAIN. HE SUSPECTS THE BLEEDING BEGAN WHEN THE PATIENT RUBBED HIS CHEEK, CAUSING MECHANICAL DISRUPTION, DURING THE TIME BETWEEN DISCHARGE AND THE POST-OPERATIVE VISIT THE FOLLOWING MORNING. DR. (B)(6) DOES NOT FEEL THE HEMATOMA IS IN ANYWAY RELATED TO THE HEMOBLAST BELLOWS.

    Description of Event or Problem · 1

    SURGEON REPORTED THAT A SMALL HEMATOMA HAD FORMED ON THE RIGHT SIDE OF A MALE PATIENT'S FACE FOLLOWING A FACELIFT IN WHICH HEMOBLAST¿ BELLOWS WAS USED. THE DRAIN WAS NOTED TO BE PLACED SUPERIOR TO THE HEMATOMA. THE HEMATOMA WAS IDENTIFIED THE DAY AFTER SURGERY, IN A SPOT SUPERIOR TO THE DRAIN NEAR THE EAR. THE SURGEON EVACUATED 1-2 MLS OF BLOOD FROM THE AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574864 HEMOBLAST BELLOWS HEMOSTATIC AGENT PMX BIOM'UP SA BQF02 BQF17030.134149 03760193182705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention