BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INOVO INC.

    MDR report key: 18749617 · Received February 21, 2024

    Report

    Report Number
    1062191-2024-00001
    Event Type
    Malfunction
    Date Received
    February 21, 2024
    Date of Event
    February 13, 2023
    Report Date
    April 17, 2024
    Manufacturer
    INOVO INC.
    Product Code
    ILS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INOVO INC. PREVIOUSLY REPORTED THE INCORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER AS 2/13/2023. THE CORRECT DATE FOR SECTION G3, DATE RECEIVED BY MANUFACTURER IS 1/3/2024.

    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. THE MANUFACTURER INCORRECTLY REPORTED THIS ISSUE UNDER FEI (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48488 INOVO INC. ADAPTOR, HYGIENE ILS INOVO INC. BTUF-8130M-BB

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown