BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERIDIAN

    MDR report key: 7786205 · Received August 15, 2018

    Report

    Report Number
    3003801933-2018-00003
    Event Type
    Injury
    Date Received
    August 15, 2018
    Date of Event
    May 21, 2018
    Report Date
    July 19, 2018
    Manufacturer
    EEZCARE MEDICAL CORP.
    Product Code
    FNM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    WE HAD GIVEN EFFORTS, BUT CAN NOT OBTAIN ANY MORE INFORMATION FROM IMPORTER, AND THE INITIAL REPORT FROM IMPORTER SHOW ONLY MENTION " ADVERSE EVENT" BUT NOT "PRODUCT PROBLEM" (EG. DEFECTS/MALFUNCTIONS), ALSO SHOW AS (B)(4) "ADVERS EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM", SO WE THINK THE ADVERSE EVENT MIGHT HAPPENED BY SOME OTHER CAUSE.

    Description of Event or Problem · 1

    PATIENT WAS FOUND FACE DOWN NEXT TO HER BED IN THE LOWEST POSITION WITH THE BOLSTERS IN PLACE. FACILITY STAFF CALLED 911 & END USER WAS TRANSFERRED FROM ER TO VIPU WITH CONFIRMED LEFT HIP FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    626806 MERIDIAN 8" APM - 8LPM PUMP WITH FOAM BASE, PRODUCT CODE: FNM FNM EEZCARE MEDICAL CORP. MER-4500

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization