BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHILADELPHIA CERVICAL COLLAR, MEDIUM, 4-1/4

    MDR report key: 3831818 · Received March 6, 2014

    Report

    Report Number
    1526350-2014-00159
    Event Type
    Malfunction
    Date Received
    March 6, 2014
    Date of Event
    January 22, 2014
    Report Date
    February 5, 2014
    Manufacturer
    ZIMMER SURGICAL
    Product Code
    IQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER ORDERED THE MEDIUM PHILLI CERVICAL COLLAR AND RECEIVED A LARGE INSIDE A MEDIUM COLLAR BAG. THERE WAS NO PATIENT HARM OR DELAY REPORTED, AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135690 PHILADELPHIA CERVICAL COLLAR, MEDIUM, 4-1/4 PHILADELPHIA CERVICAL COLLAR, MEDIUM IQK ZIMMER SURGICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1