BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAMMBERGER SINU-FOAM NASAL DRESSING

    MDR report key: 2322718 · Received October 12, 2011

    Report

    Report Number
    2951580-2011-00155
    Event Type
    Malfunction
    Date Received
    October 12, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 26, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LYA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT'S AGE AND GENDER WAS REQUESTED BUT NOT RECEIVED. REFERENCE MFR'S REPORT#: 2951580-2011-00154.

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PHYSICIAN WAS TREATING THE PT WITH STAMMBERGER SINU-FOAM NASAL DRESSING POST-OPERATIVE. WHILE MIXING THE DRY FIBER WITH THE RECOMMENDED AMOUNT OF STERILE WATER, THE PHYSICIAN REPORTED THE MIXTURE DID NOT BECOME VISCOUS; REMAINING "RUNNY." THE PT WAS TREATED WITH A COMPETITOR'S PRODUCT. NO 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 SPLINT, INTRANASAL SEPTAL LYA ARTHROCARE CORP. 4119210-

    Patients

    Seq Age Sex Outcome Treatment
    1