BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRA COMFRT, SE 4X30 DOMESTIC

    MDR report key: 9831485 · Received March 13, 2020

    Report

    Report Number
    0001831750-2020-00313
    Event Type
    Injury
    Date Received
    March 13, 2020
    Date of Event
    February 14, 2020
    Report Date
    April 10, 2020
    Manufacturer
    STRYKER MEDICAL-KALAMAZOO
    Product Code
    IKY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS NOT DUE TO ANY SPECIFIC COMPONENT MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED BY MEDWATCH FORM 3500 SUBMITTED BY THE USER FACILITY THAT DURING TRANSFER OF A PATIENT FROM A STRETCHER TO AN OR TABLE, THE MATTRESS SLID WITH THE PATIENT AND THE PATIENT WAS SUBSEQUENTLY STUCK BETWEEN THE STRETCHER AND OR TABLE. THE STAFF SUCCESSFULLY TRANSFERRED THE PATIENT, HOWEVER A CONTRACTED EMPLOYEE SUSTAINED AN UNKNOWN MUSCULAR/SKELETAL INJURY. NO INJURY WAS REPORTED FOR THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY MEDWATCH FORM 3500 SUBMITTED BY THE USER FACILITY THAT DURING TRANSFER OF A PATIENT FROM A STRETCHER TO AN OPERATING ROOM (OR) TABLE, THE MATTRESS SLID WITH THE PATIENT AND THE PATIENT WAS SUBSEQUENTLY STUCK BETWEEN THE STRETCHER AND OPERATING ROOM (OR) TABLE. THE STAFF SUCCESSFULLY TRANSFERRED THE PATIENT, HOWEVER A CONTRACTED EMPLOYEE SUSTAINED AN UNKNOWN MUSCULAR/SKELETAL INJURY. NO INJURY WAS REPORTED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294292 ULTRA COMFRT, SE 4X30 DOMESTIC MATTRESS, FLOTATION THERAPY, NON-POWERED IKY STRYKER MEDICAL-KALAMAZOO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other