BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AQUAPLAST PELLETS

    MDR report key: 4384694 · Received December 22, 2014

    Report

    Report Number
    4384694
    Event Type
    Malfunction
    Date Received
    December 22, 2014
    Date of Event
    November 13, 2014
    Report Date
    December 22, 2014
    Manufacturer
    QFIX
    Product Code
    EPP
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AQUAPLAST BEADS USED TO CREATE CUSTOM FITTING BOLUS FOR FILLING BILATERAL NASAL CAVITY/VESTIBULES FOR NASAL SEPTUM SQUAMOUS CELL CA. WHEN IT HARDENED, THE EXTERNAL TIPS OF MATERIAL FUSED, CREATING A SEMICIRCULAR "RING: OF AQUAPLAST THAT COULD NOT BE READILY REMOVED FROM THE PATIENT'S NASAL CAVITY, AS THE SPACE BETWEEN THE INTERNAL PART OF THE AQUAPLAST "RING" WAS TOO NARROW PASS AROUND THE INFERIOR TIP OF NASAL SEPTUM. THE PATIENT REQUIRED AN OTOLARYNGOLOGIST TO DIVIDE THE FUSED EXTERNAL BRIDGE BETWEEN BOLUS MATERIAL IN LEFT AND RIGHT NASAL CAVITIES TO REMOVE FROM THE PATIENT'S NOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843150 AQUAPLAST PELLETS SPLINT, NASAL EPP QFIX RT- 7001 *

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR ONLY WARNING WAS TO NOT USE IN MOUTH
    2 67 YR