BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HUGO

    MDR report key: 5404325 · Received January 18, 2016

    Report

    Report Number
    8022077-2015-00107
    Event Type
    Injury
    Date Received
    January 18, 2016
    Date of Event
    August 9, 2015
    Report Date
    January 13, 2016
    Manufacturer
    AMG MEDICAL INC.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CLAIMANT (B)(6) WAS INJURED WITH BUMPS, SCRAPES, AND BRUISES WHEN SHE FELL OVER. (B)(6) WERE INJURED TRYING TO STOP THEIR MOM FROM FALLING OVER AND GETTING HURT. ALL OF THE INJURIES ARE MINOR AND ONLY (B)(6) ARE DOCUMENTED BY PHOTOS. THE HUGO ROLLATOR 700-959 WAS SENT BACK TO (B)(6) WAREHOUSE IN (B)(6) AND THE CAUSE WAS DETERMINED TO BE A DEFECTED WHEEL BOLT THAT BROKE IN HALF. THE DEFECTIVE UNIT WAS SENT TO OUR (B)(6) OFFICE BUT WE NEVER RECEIVED IT. WE SENT HER A NEW REPLACEMENT ROLLING WALKER. WE HAVE ONLY HAD ONE OTHER SIMILAR INCIDENT WHERE THE BOLT BROKE IN HALF. WE HAD DONE AN INTERNAL INVESTIGATION FOR THAT CASE AND IT WAS DEEMED TO BE AN ISOLATED OCCURRENCE.

    Description of Event or Problem · 1

    IT WAS ON (B)(6) 2015. (B)(6) WAS SITTING STATIONARY ON THE BENCH SEATING OF THE HUGO ROLLING WALKER WHILE WAITING TO GAIN ENTRANCE TO THE FLEA MARKET. WHILE (B)(6) WAS STATIONED IN THE SEAT OF THE ROLLING WALKER (B)(6) NOTICED THAT THE ROLLING WALKER STARTED TIPPING AND LEANING TOWARDS THE LEFT. (B)(6) IMMEDIATELY TRIED HOLDING THE ROLLATOR UPRIGHT TO PREVENT (B)(6) FROM FALLING TO THE CEMENT. MEANWHILE (B)(6) HURDLED OVER TO ASSIST. BOTH WERE UNSUCCESSFUL IN PREVENTING (B)(6) FROM CRASHING TO THE CEMENT. THE ROLLATOR TIPPED AND FELL BACKWARDS HAVING (B)(6) FALLING BACKWARDS HITTING HER HEAD ON THE CEMENT AND THE ROLLATOR LANDING ON TOP OF HER. THERE WAS AN OFF DUTY EMS WORKER THAT WAS NEARBY THAT CAME TO ASSIST AND EVALUATE THE INJURIES. HE BANDAGED (B)(6) CALF AND PUT AN (B)(6) BANDAGE ON (B)(6) ANKLE AND PROVIDED ICE PACKS FOR BOTH. (B)(6) DENIED IMMEDIATE EMERGENCY ASSISTANCE AT THE SCENE. THE OFF DUTY EMS EMPLOYEE GAVE INSTRUCTIONS TO CONTINUE ICING AND WATCH FOR ANY SIGNS OF A CONCUSSION AND ADDITIONAL BRUISING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34377 HUGO HUGO ELITE ROLLING WALKER ITJ AMG MEDICAL INC. 700-959

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other