BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEMOBLAST BELLOWS

    MDR report key: 8781502 · Received July 11, 2019

    Report

    Report Number
    3007702492-2019-00001
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    February 27, 2019
    Report Date
    May 15, 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

    THE FILING OF THIS REPORT WAS DELAYED BECAUSE BIOM'UP MADE SEVERAL ATTEMPTS TO OBTAIN PATIENT INFORMATION AND DEVICE INFORMATION, SUCH AS LOT # AND EXPIRATION DATE, TO FACILITATE INVESTIGATION IF THE ISSUE, HOWEVER THE INFORMATION WAS NOT PROVIDED.

    Description of Event or Problem · 1

    PHYSICIAN PERFORMED CAPSULECTOMY AND REMOVED SUBPECTOL BREAST IMPLANT. HEMOBLAST BELLOWS WAS APPLIED OVER MUSCLE, ESPECIALLY IN AXILLARY REGION. THE AREA WAS OBSERVED TO BE DRY WHEN SKIN WAS CLOSED. WITHIN 7 HOURS POST-OP THE PATIENT HAD SWELLING ON LEFT SIDE. PATIENT WAS RETURNED TO OPERATING ROOM AND 500 - 1000 ML BLOOD WAS EVACUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573307 HEMOBLAST BELLOWS HEMOSTATIC AGENT PMX BIOM'UP SA BQF02 03760193182705

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention