BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BAR,GRAB,SUCTION,12/CS

    MDR report key: 17711565 · Received September 8, 2023

    Report

    Report Number
    1417592-2023-00369
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    July 16, 2023
    Report Date
    November 19, 2024
    Manufacturer
    CAREX
    Product Code
    ILS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATE TO D3: MANUFACTURER, UPDATE TO D9: SAMPLE RECEIVED, UPDATE TO H3: DEVICE EVALUATED, UPDATE TO H6: TYPE OF INVESTIGATION, UPDATE TO H6: INVESTIGATION CONCLUSIONS. THE REPORTED ISSUE IS ASSOCIATED WITH A NON-MEDLINE LABELED PRODUCT. THE SAMPLE RECEIVED CAME WITH THE ORIGINAL PACKAGING WHICH IS LABELLED AS CAREX. AFTER FURTHER INVESTIGATION IT HAS BEEN DETERMINED THAT THIS IS A CAREX PRODUCT. THE INITIAL REPORTED ISSUE IS NOT REPORTABLE BY MEDLINE INDUSTRIES, LP. A THIRD-PARTY NOTIFICATION WAS PERFORMED WITH CAREX. NO FURTHER REGULATORY INVESTIGATION WILL BE PERFORMED BY MEDLINE INDUSTRIES, LP. RELATED TO THIS INCIDENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE REOPENED AND REEVALUATED.

    Additional Manufacturer Narrative · 0

    ACCORDING TO THE CUSTOMER, HE WENT TO GRAB THE BAR WHILE IN THE SHOWER AND THE "SUCTION CUPS CAME OFF THE SHOWER WALL" CAUSING HIM TO FALL AND HURT HIS "HIP AND LOWER BACK". THE CUSTOMER REPORTED HE REQUIRED ASSISTANCE TO GET UP AFTER THE REPORTED INCIDENT OCCURRED AND HAD "PAIN, BRUISING, AND SWELLING". THE CUSTOMER REPORTED HIS DOCTOR IS ADMINISTERING A "STEROID INJECTION IN A FEW DAYS" FOR HIS LEFT HIP AND HAS ORDERED PHYSICAL THERAPY. SAMPLE REQUESTED FOR RETURN EVALUATION. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO SERIOUS INJURY, THEREFORE, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER, HE WENT TO GRAB THE BAR WHILE IN THE SHOWER AND THE "SUCTION CUPS CAME OFF THE SHOWER WALL" CAUSING HIM TO FALL AND HURT HIS "HIP AND LOWER BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524503 BAR,GRAB,SUCTION,12/CS ILS CAREX

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other