BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    "ONGE" NEURP STRIP 1/2IN

    MDR report key: 4752558 · Received April 30, 2015

    Report

    Report Number
    MW5042512
    Event Type
    Malfunction
    Date Received
    April 30, 2015
    Date of Event
    March 20, 2015
    Report Date
    April 30, 2015
    Manufacturer
    PILLING WECK INC
    Product Code
    EFQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THESE SPONGES ARE INSERTED IN THE NASAL CAVITY AFTER SURGERY TO CATCH AND ABSORB BLOOD, MEDICATION AND MUCUS. THE SURGEON THEN REMOVES THEM PRIOR TO PT DISCHARGE. THE SURGEONS HAVE NOTICED THAT SINCE SWITCHING TO THE PILLING NEUROSPONGES, WHEN THEY GO TO REMOVE THEM, THEY ARE SHREDDING AND TEARING. THIS MAKES IT DIFFICULT FOR BOTH THE PT AND THE SURGEON SINCE WE USUALLY HAVE TO THEN INSERT LONG FORCEPS TO REMOVE ANY BROKEN OFF PIECES OF SPONGE. LEAVING A SPONGE IN THE PT CAVITY THAT IS COVERED IN BLOOD AND MUCUS WILL LEAD TO A FOUL ODOR AND POSSIBLE INFECTION. WE HAVE REMOVED ALL PILLING SPONGES FROM OUT SUPPLY AND ARE NOW LOOKING AT OTHER MANUFACTURERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286219 "ONGE" NEURP STRIP 1/2IN EFQ PILLING WECK INC

    Patients

    Seq Age Sex Outcome Treatment
    1