BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DRIVE MEDICAL

    MDR report key: 5530416 · Received March 28, 2016

    Report

    Report Number
    2438477-2016-00015
    Event Type
    Injury
    Date Received
    March 28, 2016
    Date of Event
    February 23, 2016
    Report Date
    February 26, 2016
    Manufacturer
    A & I VIETNAM MEDICAL EQUIPMENT CO., LTD
    Product Code
    IOR
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    (B)(4) RECEIVED NOTICE REGARDING THE INCIDENT FROM THE PROVIDER INVOLVING A WHEELCHAIR, A PRODUCT IMPORTED AND DISTRIBUTED BY (B)(4). THE END USER WAS PUSHING THE SEAT DOWN TO GET IT TO LATCH. HER FINGER WAS ALLEGEDLY PINCHED IN THE MECHANISM WHEN THE SEAT CLOSED ON HER, AND THE FINGER WAS AMPUTATED AS A RESULT. THIS REPORT IS BASED ON THE INFORMATION PROVIDED FROM THE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184735 DRIVE MEDICAL WHEELCHAIR IOR A & I VIETNAM MEDICAL EQUIPMENT CO., LTD STD28DFA

    Patients

    Seq Age Sex Outcome Treatment
    1 95 YR Required Intervention