BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJUSTABLE AUTOMATIC DONOR SCALE

    MDR report key: 286641 · Received July 11, 2000

    Report

    Report Number
    1036337-2000-00002
    Event Type
    Injury
    Date Received
    July 11, 2000
    Date of Event
    June 15, 2000
    Report Date
    June 30, 2000
    Manufacturer
    HIGHLAND LABORATORIES
    Product Code
    KSQ
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CENTER REPORTED THAT A DONOR WAS WALKING PAST AN AUTOMATIC DONOR SCALE THAT WAS ATTACHED TO A DONOR CHAIR. THE DONOR CAME INTO CONTACT WITH THE AUTOMATIC DONOR SCALE AND REC'D WHAT WAS DESCRIBED AS A 2 INCH LACERATION WITH ACTIVE BLEEDING. THE CARE GIVEN WAS DESCRIBED AS FOLLOWS: THE AREA WAS MADE TO BLEED AND WAS SCRUBBED FOR 3 MINUTES WITH GREEN SOAP AND ALCOHOL. IT WAS THEN SCRUBBED WITH BETADINE AND PREPPED WITH BACDOWN STERILE DRESSING. THE DONOR HAD CURRENT TETANUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADJUSTABLE AUTOMATIC DONOR SCALE ADJUSTABLE AUTOMATIC DONOR SCALE KSQ HIGHLAND LABORATORIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention