BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 5427256 · Received February 1, 2016

    Report

    Report Number
    8022077-2015-00180
    Event Type
    Injury
    Date Received
    February 1, 2016
    Date of Event
    October 5, 2015
    Report Date
    January 28, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WHEN SHE INITIALLY CONTACTED US ON (B)(6) 2015 SHE STATED THAT SHE FELL BUT THERE WAS NO INJURY. SHE REQUESTED A REPLACEMENT ROLLING WALKER AND WE SENT HER THE SAME MODEL, HUGO ROLLING WALKER WITH A SEAT 700-957. SHE CONTACTED US AGAIN ON (B)(6) 2016 STATING THIS TIME THAT SHE SUSTAINED INJURY TO HER RIGHT KNEE AND THAT SHE STILL HAS SWELLING AND PAIN FROM IT AND SHE DISCLOSED HER WEIGHT WHICH IS (B)(6). SHE ALSO STATED THAT THE SECOND REPLACEMENT ROLLING WALKER WE SENT HER BROKE BUT SHE DID NOT FALL OR SUSTAIN ANY INJURY. THE 700-957 HUGO ROLLING WALKER IS DESIGNED TO SUPPORT ADULTS UP TO 300 LBS AS STATED IN THE INSTRUCTION MANUAL AS FOLLOWS. WE SENT HER A DIFFERENT MODEL OF ROLLING WALKER THIS TIME, THE 700-928 AIRGO EXCURSION XWD ROLLING WALKER WHICH HAS A MAXIMUM WEIGHT CAPACITY OF 400LBS. THIS CASE IS CONSIDERED CLOSED AS IT IS MISUSE OF THE ROLLING WALKER DUE TO HER WEIGHT.

    Description of Event or Problem · 1

    THE HUGO ROLLING WALKER LEG BROKE LAST NIGHT AS THE CUSTOMER WAS WALKING FROM ONE ROOM TO THE NEXT, THROWING HER OFF KILTER AND CAUSING HER TO FALL TO THE FLOOR. NO INJURIES WERE SUSTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61701 HUGO HUGO ROLLING WALKER WITH A SEAT ITJ AMG MEDICAL INC. 700-957

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other