BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSPIRED BY DRIVE

    MDR report key: 16844024 · Received May 1, 2023

    Report

    Report Number
    3005328749-2023-00001
    Event Type
    Injury
    Date Received
    May 1, 2023
    Report Date
    May 1, 2023
    Manufacturer
    INOVO INC
    Product Code
    ILS
    UDI-DI
    00822383974552
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    INOVO WAS NOTIFIED OF A COMPLAINT INVOLVING A BATH TRANSFER BENCH BY AN END USER'S MOTHER, WHO STATED "THE TUB BASE LEG THAT TELESCOPES WENT IN, GETTING SHORTER [AND] CAUSING MY SON TO FALL IN THE TUB." THERE WAS NO REPORT OR EVIDENCE OF ILLNESS, INJURY OR MEDICAL TREATMENT ASSOCIATED WITH THE COMPLAINT. THE END USER'S MOTHER STATED SHE WILL NOT BE RETURNING THE PRODUCT FOR INVESTIGATION. INOVO WILL CONTINUE TO MONITOR COMPLAINTS FOR ANY RELATED TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275882 INSPIRED BY DRIVE BATH TRANSFER ILS INOVO INC BTUF-8130M-BB 00822383974552

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Male