BEUDAMED
    FDA Adverse Event No answer provided Summary report: N

    DRIVE

    MDR report key: 13655277 · Received March 2, 2022

    Report

    Report Number
    2438477-2022-00006
    Event Type
    No answer provided
    Date Received
    March 2, 2022
    Date of Event
    January 17, 2022
    Report Date
    March 2, 2022
    Manufacturer
    NINGBO SHENYU MEDICAL EQUIPMENT
    Product Code
    ITJ
    UDI-DI
    00822383233222
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    DRIVE DEVILBISS WAS NOTIFIED OF AN ADVERSE INCIDENT INVOLVING A ROLLATOR ON (B)(6) 2022. THE USER REPORTED "I WAS JUST SITTING ON MY WALKER OUTSIDE, AND THE WHEEL FELL OFF AND I FELL CRACKING MY HEAD ON THE CEMENT GROUND." HER DOCTOR'S OFFICE WAS CLOSED AND THERE WAS NO BLOOD, BUT SHE HAD A "MASSIVE HEADACHE." WHEN ASKED FOR PHOTOS OF THE DEVICE SHE ADVISED THAT SHE DID NOT KNOW HOW TO SEND PHOTOS FROM HER PHONE AND THAT SHE NEEDED TO WAIT UNTIL LATER. AT THE PRESENT WE HAVE NOT RECEIVED AWAITING THE EMAIL WITH THE PHOTOS. SHE WAS SCHEDULED TO SEE HER DOCTOR EARLY (B)(6); HOWEVER, WE HAVE BEEN UNABLE TO ACQUIRE ANY ADDITIONAL DATA. DRIVE IS CURRENTLY INVESTIGATING THE INCIDENT, INCLUDING ATTEMPTING TO RETRIEVE THE PRODUCT AND INSPECT IT, AND WILL FILE AN UPDATE AS SOON AS ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266390 DRIVE ROLLATOR ITJ NINGBO SHENYU MEDICAL EQUIPMENT R726RD 00822383233222

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other