BEUDAMED
    FDA Adverse Event Other Summary report: N

    UNKNOWN POST-OP KIT

    MDR report key: 2023688 · Received February 18, 2011

    Report

    Report Number
    1644019-2011-00007
    Event Type
    Other
    Date Received
    February 18, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ALCON - HOUSTON
    Product Code
    KYG
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A REP OF A CLINIC REPORTED THAT A FEMALE PT EXPERIENCED A REACTION TO THE TAPE AND IT WAS DIFFICULT TO REMOVE FROM HER FACE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, INCLUDING, BUT NOT LIMITED TO, THE SPECIFIC REACTION, DURATION AND SEVERITY OF REACTION, WHETHER TREATMENT WAS NEEDED, AND CURRENT CONDITION OF THE PT. TO DATE, NO FURTHER INFORMATION HAS BEEN REC'D.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN POST-OP KIT POST-OP KIT KYG ALCON - HOUSTON UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other