BEUDAMED
    FDA Adverse Event Other Summary report: N

    CAREKITS LACERATION TRAY

    MDR report key: 66780 · Received January 31, 1997

    Report

    Report Number
    1528105-1997-90001
    Event Type
    Other
    Date Received
    January 31, 1997
    Date of Event
    January 18, 1997
    Report Date
    January 31, 1997
    Manufacturer
    J J SKINNER, INC.
    Product Code
    LRP
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    USER ERROR: MARKETING SAMPLE LABELED AS NON-STERILE/SAMPLE ONLY USED BY HOSP PERSONNEL (NON-STERILE LACERATION KIT SAMPLE USED FOR TREATMENT OF SMALL LACERATION BY ER PERSONNEL)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAREKITS LACERATION TRAY CONVENIENCE KIT LRP J J SKINNER, INC. NA NA(NON-STERILE SAMPLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other