BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BERKETTE BEACH CHAIR LIMB POSITIONER

    MDR report key: 24981539 · Received April 24, 2026

    Report

    Report Number
    3002750084-2026-00041
    Event Type
    Malfunction
    Date Received
    April 24, 2026
    Date of Event
    March 27, 2026
    Report Date
    April 24, 2026
    Manufacturer
    ASPEN SURGICAL PRODUCTS, INC.
    Product Code
    CCX
    UDI-DI
    00840113230662
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION, BUT PICTURES WERE PROVIDED SO THE COMPLAINT COULD BE CONFIRMED. THE INVESTIGATION CONCLUDED THAT THE BREAKAGE OF THE BRACKET HANDLE WAS DUE TO A DEVICATION ATTRIBUTABLE TO THE EXTERNAL SUPPLIER THAT PROVIDES THIS COMPONENT. THE SUPPLIER WAS NOTIFIED, AND CORRECTIVE ACTIONS ARE BEING FOLLOWED UP. THE ROOT CAUSE IS A MANUFACTURING ERROR. THIS SHOULD BE CONSIDERED THE FINAL REPORT. IF ANY ADDITIONAL RELEVANT INFORMATION IS IDENTIFIED IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 0

    COMPLAINANT ALLEGES "THIS MORNING WE HAD THE HANDLE ON THE BERKETTE BREAK OFF WHILE GETTING THE PATIENT POSITIONED. THIS HAPPENED 3 TIMES TO 3 DIFFERENT PRODUCTS ALL WITH THE SAME LOT# OF 110525. HOPEFULLY YOU CAN TELL FROM THE PICTURES BELOW, BUT THE HANDLE SNAPPED WHERE IT IS COVERED BY THE GRIP."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246060 BERKETTE BEACH CHAIR LIMB POSITIONER PATIENT POSITIONING CCX ASPEN SURGICAL PRODUCTS, INC. 711200 110525 00840113230662

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown