BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREEDOM BED

    MDR report key: 14958185 · Received July 7, 2022

    Report

    Report Number
    MW5110759
    Event Type
    Injury
    Date Received
    July 7, 2022
    Date of Event
    July 27, 2021
    Report Date
    June 26, 2022
    Manufacturer
    PROBED MEDICAL TECHNOLOGIES, INC.
    Product Code
    IKZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I AM A RESIDENT IN A (B)(6) LIVING CENTER. THE AIR MATTRESS CIRCULATED TO THE AREAS OF LEAST RESISTANCE CAUSING SHARP EDGES OF THE AIR POCKETS TO ¿ELEVATE¿ AND PRESS ON THE SCROTAL AND ANAL AREAS, CAUSING SEVERE PAIN. ON NUMEROUS OCCASIONS, WHEN THE BED COMPUTER FAILED TO FUNCTION PROPERLY, THE AIR MATTRESS WOULD SIMPLY COLLAPSE LEAVING ME ON THE HARD METAL FRAME, CAUSING SEVERE LUMBAR PAIN. ON OTHER OCCASIONS, THE AIR MATTRESS WOULD INFLATE SO MUCH THAT MY KNEES WOULD BE TRAPPED UNDER THE OVERBED TABLE, AND THE MATTRESS WOULD PUSH MY KNEES AGAINST THE OVERBED TABLE TRYING TO LIFT IT CAUSING SEVERE KNEE PAIN. MY LEFT KNEE WAS X-RAYED AND SHOWED NO FRACTURE, BUT THE PAIN WAS INTENSE. I REQUIRED ICE PACKS AND A TOPICAL ANALGESIC CREAM FOR SOME RELIEF. THESE EVENTS CAUSED ME SEVERE NEW AND ADDITIONAL PAIN THAT I HAD NOT PREVIOUSLY EXPERIENCE DUE TO MY ON-GOING DISABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1908278 FREEDOM BED BED, PATIENT ROTATION, POWERED IKZ PROBED MEDICAL TECHNOLOGIES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Other| S CURRENT PRESCRIPTION MEDICATIONS: CALCIUM| CURRENT PRESCRIPTION MEDICATIONS: DAILY VITAMIN.| CURRENT PRESCRIPTION MEDICATIONS: GABAPENTIN.| CURRENT PRESCRIPTION MEDICATIONS: INSULIN ASPARTANE.| CURRENT PRESCRIPTION MEDICATIONS: INSULIN LANTUS.| CURRENT PRESCRIPTION MEDICATIONS: OTHER MEDICATIONS BEING DISPENSED BY CLC NURSE.| CURRENT PRESCRIPTION MEDICATIONS: TYLENOL.