BEUDAMED
    FDA Adverse Event Death Summary report: N

    MATTRESS COVER FOR MEDICAL PURPOSES.

    MDR report key: 17537006 · Received August 12, 2023

    Report

    Report Number
    MW5143888
    Event Type
    Death
    Date Received
    August 12, 2023
    Date of Event
    June 5, 2018
    Report Date
    June 13, 2018
    Manufacturer
    TRIDIEN
    Product Code
    FMW
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    I RECEIVED A CALL FROM (B)(6) HC AND REHAB REGARDING SERVICE ORDER (B)(4). PER (B)(6) AFTER THE EQUIPMENT WAS DELIVERED THE PATIENT WAS THEN PLACED ONTO THE MATTRESS, ONCE HE WAS PUT ON TO THE MATTRESS THE PATIENT THEN STOPPED BREATHING. (B)(6) PROCEEDED TO INFORM ME THAT THE PARAMEDICS WERE CALLED AND CAME OUT TO TRY AND REVIVE THE PATIENT. WERE THERE ANY INJURIES? : YES. WAS MEDICAL ATTENTION REQUIRED ?: YES. WHAT WERE THE INJURIES? : DEATH. THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1049834 MATTRESS COVER FOR MEDICAL PURPOSES. COVER, MATTRESS (MEDICAL PURPOSES) FMW TRIDIEN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown