BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTOLAM

    MDR report key: 251148 · Received November 24, 1999

    Report

    Report Number
    MW1017622
    Event Type
    Malfunction
    Date Received
    November 24, 1999
    Report Date
    November 24, 1999
    Manufacturer
    SHARPLAN LASERS, INC.
    Product Code
    EWG
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    OTOLARYNGOLOGIST WHO HAS BEEN INVOLVED WITH THE DEVICE REVIEW PROCESS FOR THIS DEVICE HAS "SERIOUS" CONCERNS REGARDING THE LACK OF LONG-TERM RISK DATA ON THIS DEVICE WHEN USED FOR REPEATED TREATMENT OF RECURRENT EAR INFECTIONS. DR IS ALSO CONCERNED THAT THE DEVICE IS BEING AGGRESSIVELY MARKETED TOWARD NON-SURGICALLY TRAINED PEDIATRICIANS AND PARENTS. REPORTER STATES IN HIS CONVERSATIONS WITH THE MFR REP, THE CO PLAINLY ADMITS TO NOT HAVING DATA ON THE LONG-TERM EFFECTS OF THIS PROCEDURE. THERE IS NO LONG-TERM SAFETY DATA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTOLAM CO2 LASER EWG SHARPLAN LASERS, INC. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA