BEUDAMED
    FDA Adverse Event Other Summary report: N

    EQUATE COTTON SWAB

    MDR report key: 85188 · Received April 16, 1997

    Report

    Report Number
    1218939-1997-00007
    Event Type
    Other
    Date Received
    April 16, 1997
    Date of Event
    February 26, 1997
    Report Date
    April 16, 1997
    Manufacturer
    AMERICAN WHITE CROSS, INC.
    Product Code
    KXF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    USER WAS CLEANING EAR WITH COTTON SWAB WHEN TIP CAME OFF STICK AND LODGED IN EAR CANAL. COTTON WAS REMOVED BY A PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUATE COTTON SWAB COTTON TIPPED SWAB KXF AMERICAN WHITE CROSS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention