BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROLLATOR 20 IN 250LB 5 IN WHEELS

    MDR report key: 12328859 · Received August 16, 2021

    Report

    Report Number
    1423537-2021-00662
    Event Type
    Injury
    Date Received
    August 16, 2021
    Date of Event
    April 14, 2021
    Report Date
    August 16, 2021
    Manufacturer
    JAN MAO INDUSTRIES CO., LTD.
    Product Code
    ITJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD FOR THE REPORTED PRODUCT COULD NOT BE REVIEWED SINCE THE LOT NUMBER WAS NOT PROVIDED. THIS IS THE FIRST COMPLAINT REPORTED ON THIS PRODUCT FOR THIS TYPE OF ISSUE IN THE PAST TWELVE MONTHS. ACCORDING TO SUPPLIER, THERE WERE NO CHANGES TO DESIGN, PRODUCTION PROCESS, OR RELATED MATERIALS. THE COMPLAINT SAMPLE AND LOT NUMBER WERE NOT AVAILABLE FOR INVESTIGATION; THEREFORE, THE SUPPLIER WAS UNABLE TO DETERMINE THE ROOT CAUSE. THE SUPPLIER WILL CONTINUE TO MONITOR TRENDS FOR THIS TYPE OF INCIDENT.

    Description of Event or Problem · 1

    PLAINTIFF ALLEGES ¿THE ROLLATOR SUDDENLY AND UNEXPECTEDLY BROKE DROPPING MS. (B)(6) ONTO THE FLOOR AND THE METAL OF THE BROKEN ROLLATOR SLICED HER ARM AS SHE FELL REQUIRING A THREE-DAY HOSPITAL STAY. MS. (B)(6) HAD USED THE ROLLATOR FOR LESS THAN TWO MONTHS WHEN THIS PRODUCT MALFUNCTION OCCURRED.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1222577 ROLLATOR 20 IN 250LB 5 IN WHEELS WALKER, MECHANICAL ITJ JAN MAO INDUSTRIES CO., LTD. CRL0008R UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R