BEUDAMED
    FDA Adverse Event Death Summary report: N

    METHYL METHACRYLATE

    MDR report key: 26545 · Received August 14, 1995

    Report

    Report Number
    26545
    Event Type
    Death
    Date Received
    August 14, 1995
    Date of Event
    August 7, 1995
    Report Date
    August 10, 1995
    Manufacturer
    HOWMEDICA, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO HOSP E.R. AFTER SUSTAINING A FALL AT A NURSING HOME. SHE WAS ADMITTED TO THE HOSP FOR REPAIR OF A LEFT FEMORAL NECK FRACTURE. THE PT WAS A NON-AMBULATORY BUT WAS ABLE, AT TIMES, TO GET UP FROM HER WHEELCHAIR. INTRAOPERATIVELY, METHYL METHACRYLATE WAS MIXED & FORCED UNDER PRESSURE INTO THE INTERSTICES. THE COMPONENTS WERE FOUND TO BE IN GOOD POSITION ON RADIOGRAPHIC EXAMINATION. THE WOUND WAS CLOSED & THE PT WAS TRANSFERRED TO A GURNEY. AT THIS POINT, THE PT SUFFERED A CARDIAC ARREST. RESUSCITATIVE MEASURES WERE INSTITUTED BUT WERE UNSUCCESSFULL. PT'S BLOOD PRESSURE DROPPED TO 80/40 PRIOR TO INSERTION OF GLUE & CARDIAC ARREST OCCURRED 15 MINUTES AFTER APPLICATION OF METHYL METHACRYLATE. ADD'L MODEL # STERILIZATION 250694 & 940661.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 METHYL METHACRYLATE METHYL METHACRYLATE LOD HOWMEDICA, INC. BATCH# 177EB & 866FB

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death