BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STAMMBERGER SINU-FOAM NASAL DRESSING

    MDR report key: 2852663 · Received November 14, 2012

    Report

    Report Number
    3006524618-2012-00888
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ARTHROCARE CORPORATION
    Product Code
    LYA
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT IDENTIFIER, AGE, WEIGHT AND GENDER WERE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN MIXED THE STAMMBERGER SINU-FOAM NASAL DRESSING AND IT DID NOT MIX PROPERLY. INFO PROVIDED INDICATES THE PROCEDURE WAS COMPLETED WITHOUT FURTHER COMPLICATIONS AND THAT NO OTHER PRODUCT WAS USED. 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 NASAL DRESSING LYA ARTHROCARE CORPORATION 4116320-A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other