BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MED AIRE

    MDR report key: 14021572 · Received April 6, 2022

    Report

    Report Number
    2438477-2022-00022
    Event Type
    Injury
    Date Received
    April 6, 2022
    Report Date
    April 6, 2022
    Manufacturer
    EEZCARE MEDICAL CORP
    Product Code
    FNM
    UDI-DI
    00822383111605
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    (B)(6) HEALTHCARE WAS CONTACTED ON (B)(6) 2022 REGARDING A REPORTED INJURY INVOLVING A BARIATRIC LOW AIR LOSS MATTRESS, WHICH ARE INTENDED TO BE USED AS ONE COMPONENT OF A COMPREHENSIVE, MULTI-DISCIPLINARY PRESSURE INJURY MANAGEMENT PROGRAM. THE PATIENT'S OCCUPATIONAL THERAPIST REPORTS THAT THE PATIENT, WHO IS BED BOUND, RECEIVED THE MATTRESS IN (B)(6) 2021 AND HAD PROBLEMS WITH IT FROM THE BEGINNING, BUT WAS UNABLE TO GET THE SERVICE PROVIDER TO COME LOOK AT IT DURING THE PANDEMIC, AND NOW THE SERVICE PROVIDER WILL NOT RETURN CALLS. THE THERAPIST REPORTED THAT "THE MATTRESS WILL NOT ALTERNATE," AND THAT THE PATIENT HAS DEVELOPED 2 PRESSURE SORES DUE TO THE MATTRESS NOT FUNCTIONING PROPERLY. (B)(6) HAS YET TO RECEIVE ANY INFORMATION REGARDING THE PATIENT'S OVERALL PRESSURE INJURY MANAGEMENT PROGRAM. (B)(6) IS WORKING TO HAVE THE PRODUCT RETURNED FOR EVALUATION, AND WILL CONTINUE TO INVESTIGATE THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489366 MED AIRE BARIATRIC LOW AIR LOSS MATTRESS FNM EEZCARE MEDICAL CORP 14030 00822383111605

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other| R