BEUDAMED
    FDA Adverse Event Injury Summary report: N

    28-Z COT

    MDR report key: 9629324 · Received January 24, 2020

    Report

    Report Number
    1523574-2020-00004
    Event Type
    Injury
    Date Received
    January 24, 2020
    Report Date
    March 5, 2020
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINANT HAS PROVIDED NO ADDITIONAL DETAILS ON THE ALLEGED INCIDENT AND HAS NOT MADE THE STRETCHER AVAILABLE FOR EVALUATION BY THE MANUFACTURER. THERE HAS BEEN NO ALLEGATION OF PRODUCT MALFUNCTION BEING A FACTOR IN THE ALLEGED INCIDENT. THE STRETCHER HAS BEEN IN THE FIELD FOR 8+ YEARS. THE IFU CONTAINS INSTRUCTIONS FOR PROPER USE OF THE STRETCHER WHILE TRANSPORTING A PATIENT.

    Description of Event or Problem · 0

    THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT ON THE STRETCHER, THE PATIENT ALLEGEDLY SUSTAINED A FINGER AMPUTATION AFTER INSERTING THEIR FINGER IN AN AREA OUTSIDE OF THE PATIENT SURFACE. NO FURTHER DETAILS OR INFORMATION HAVE BEEN PROVIDED REGARDING THE ALLEGED INCIDENT DETAILS, THE DEGREE OF THE FINGER AMPUTATION SUSTAINED BY THE PATIENT OR REQUIRED MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    THE COMPLAINANT REPORTED WHILE TRANSPORTING A PATIENT ON THE STRETCHER, THE PATIENT ALLEGEDLY SUSTAINED A FINGER AMPUTATION AFTER INSERTING THEIR FINGER IN AN AREA OUTSIDE OF THE PATIENT SURFACE. NO FURTHER DETAILS OR INFORMATION HAVE BEEN PROVIDED REGARDING THE ALLEGED INCIDENT DETAILS, THE DEGREE OF THE FINGER AMPUTATION SUSTAINED BY THE PATIENT OR REQUIRED MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91466 28-Z COT 28-Z COT FPO FERNO-WASHINGTON, INC. 0012810

    Patients

    Seq Age Sex Outcome Treatment
    1 Other