BEUDAMED
    FDA Adverse Event Summary report: N

    65 SCOOP STRETCHER

    MDR report key: 6132421 · Received November 29, 2016

    Report

    Report Number
    1523574-2016-00033
    Date Received
    November 29, 2016
    Date of Event
    November 9, 2016
    Report Date
    January 30, 2017
    Manufacturer
    FERNO-WASHINGTON, INC.
    Product Code
    FPP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT PROVIDED AN INCIDENT REPORT CLARIFYING THEY EXPERIENCED DIFFICULTY IN EXTENDING THE STRETCHER INTO POSITION AND THEY BELIEVED THERE TO BE SOME TYPE OF GRINDING WHEN OPENING AND CLOSING THE STRETCHER. THE SCOOP STRETCHER WAS RETURNED AND A VISUAL AND FUNCTIONAL EVALUATION WAS CONDUCTED. THE UNIT WAS LAID FLAT ON A TABLE AND WAS THEN CYCLED OPEN AND CLOSED WITH NO ISSUES. MULTIPLE SCRATCHES AND DENTS WERE OBSERVED ON THE STRETCHER. THE STRETCHER WAS ALSO REVIEWED FOR ANY SHARP EDGES; HOWEVER, NO SHARP EDGES WERE FOUND. THE REPORTED COMPLAINT COULD NOT BE DUPLICATED AND IT IS UNKNOWN HOW THE EMT ALLEGEDLY CUT HIS HAND ON THE STRETCHER. A FOLLOW UP COMMUNICATION WAS MADE TO THE EMT AND HE STATED THE LACERATIONS WERE SUPERFICIAL IN NATURE AND HE DID NOT SEEK ANY MEDICAL INTERVENTION.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A DISTRIBUTOR THAT THEIR CUSTOMER WAS OPERATING THE SCOOP STRETCHER AND A MEDIC WAS ALLEGEDLY CUT ON A SHARP EDGE. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT. DETAILS ON THE ALLEGED INJURY AND ANY REQUIRED MEDICAL INTERVENTION WAS NOT PROVIDED IN THE INITIAL REPORT. THIS INCIDENT WILL BE FURTHER INVESTIGATED.

    Description of Event or Problem · 1

    WE RECEIVED A REPORT FROM A DISTRIBUTOR THAT THEIR CUSTOMER WAS OPERATING THE SCOOP STRETCHER AND A MEDIC WAS ALLEGEDLY CUT ON A SHARP EDGE. IT WAS NOTED THERE WAS NO INJURY TO THE PATIENT. DETAILS ON THE ALLEGED INJURY AND ANY REQUIRED MEDICAL INTERVENTION WAS NOT PROVIDED IN THE INITIAL REPORT. THIS INCIDENT WILL BE FURTHER INVESTIGATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782489 65 SCOOP STRETCHER 65 SCOOP STRETCHER FPP FERNO-WASHINGTON, INC. 0108037

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR