BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAMMBERGER SINU-FOAM NASAL DRESSING

    MDR report key: 2540914 · Received March 22, 2012

    Report

    Report Number
    3006524618-2012-00150
    Event Type
    Malfunction
    Date Received
    March 22, 2012
    Date of Event
    January 1, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    LYA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE, GENDER AND WEIGHT WERE NOT AVAILABLE. THE LOT NUMBER WAS NOT PROVIDED BY THE RPTR; THEREFORE, NO MFG OR EXPIRATION DATE CAN BE PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE MIXING THE STAMMBERGER SINU-FOAM NASAL DRESSING, THE RESULTING FOAM DID NOT REACH THE VISCOSITY REQUIRED. WITHIN MINS, THE FOAM "FLOWED" TO THE BACK OF THE NOSE AND DISAPPEARED IN THE THROAT. THE MFR WAS NOT ABLE TO OBTAIN DETAILS REGARDING THE SUBSEQUENT TREATMENT OF THE PT'S CONDITION. NO FURTHER PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STAMMBERGER SINU-FOAM NASAL DRESSING NASAL DRESSING LYA ARTHROCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R