BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAMMBERGER SINU-FOAM NASAL DRESSING

    MDR report key: 2331781 · Received October 21, 2011

    Report

    Report Number
    2951580-2011-00156
    Event Type
    Malfunction
    Date Received
    October 21, 2011
    Date of Event
    September 29, 2011
    Report Date
    October 11, 2011
    Manufacturer
    ARTHROCARE CORP.
    Product Code
    LYA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ATTEMPTS TO OBTAIN ADDITIONAL INFO REGARDING THE PT'S AGE AND GENDER WERE UNSUCCESSFUL. REFERENCE MFR'S REPORT: 2951580-2011-00157.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT (B)(6) WAS TREATED POST-OPERATIVE USING TWO PACKAGES OF THE (B)(4)SINU-FOAM NASAL DRESSING. UPON WAKING FROM ANESTHESIA, THE PT WAS COUGHING. EXAMINATION OF THE PT FOUND THAT THE NASAL FOAM WAS NOT VISCOUS ENOUGH. SUBSEQUENTLY, THE MATERIAL SLIPPED OUT OF THE SURGICAL CAVITIES OF THE SINUSES AFTER A FEW MINS AND ENDED UP IN THE NASAL PHARYNX AND THROAT OF THE PT. ALTHOUGH THE PT REPORTED SOME DISCOMFORT, 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. 4116610-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other