BEUDAMED
    FDA Adverse Event Other Summary report: N

    SHEA FOAM HEAD SUPPORT

    MDR report key: 1649777 · Received March 29, 2010

    Report

    Report Number
    1037007-2010-00003
    Event Type
    Other
    Date Received
    March 29, 2010
    Date of Event
    March 18, 2010
    Report Date
    March 29, 2010
    Manufacturer
    GYRUS ENT LLC
    Product Code
    EPW
    PMA / PMN Number
    PRE-AMEND
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER RETURNED THE DEVICE UNOPENED. THE RAZOR BLADE IN THE PACKAGE WAS LIKELY ACCIDENTALLY TRAPPED INSIDE THE PLASTIC AS THE FOAM WAS PULLED ALONG THE WORK TABLE. THE DHR WAS REVIEWED AND THERE ARE NO ISSUES WITH THE RECORD. THE LOT IS NO LONGER ON HAND. NO OTHER REPORTS FOR THE LOT. NO OTHER SIMILAR REPORTS FOR THE HEAD SUPPORTS. APPEARS TO BE AN ISOLATED EVENT.

    Description of Event or Problem · 1

    THE CUSTOMER DISCOVERED A RAZOR BLADE IN THE PACKAGE. IT WAS WITH THE DEVICE INSIDE THE SHRINK WRAP. DISCOVERED PRIOR TO REMOVING THE SHRINK WRAP AND USING THE DEVICE. NO INJURY INVOLVED, BUT THERE WAS A POTENTIAL FOR INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SHEA FOAM HEAD SUPPORT EPW GYRUS ENT LLC IH145646

    Patients

    Seq Age Sex Outcome Treatment
    1 Other