BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD HOME SHARPS CONTAINER

    MDR report key: 2151534 · Received June 24, 2011

    Report

    Report Number
    2243072-2011-00001
    Event Type
    Injury
    Date Received
    June 24, 2011
    Date of Event
    May 20, 2011
    Report Date
    June 24, 2011
    Manufacturer
    BECTON DICKINSON
    Product Code
    MMK
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT RETURN IS ANTICIPATED AS COMPLAINT INDICATES THAT THE PRODUCT HAS BEEN DISCARDED. COMPLAINT HISTORY CHECK YIELDED NO OTHER COMPLAINTS FOR SIMILAR CONDITION FOR THE LOT REPORTED. NO OBVIOUS TRENDS WERE NOTED. DEVICE HISTORY REVIEW WAS REQUESTED, WILL SUBMIT A SUPPLEMENTAL REPORT WHEN ADDITIONAL INFO BECOMES AVAILABLE. REGULATORY COMPLIANCE WILL CONTINUE TO MONITOR ON MONTHLY TREND REPORTS.

    Description of Event or Problem · 1

    CONSUMER REPORTED HER HUSBAND CUT HIS FINGER WHILE ATTEMPTING TO OPEN THE HOME SHARPS CONTAINER. CONSUMER'S HUSBAND THOUGHT THE LID WAS REMOVABLE, USED A PUTTY KNIFE TO REMOVE LID AND CUT HIMSELF WHILE ATTEMPTING TO REMOVE LID. CONSUMER'S SPOUSE WENT TO ER WHERE STITCHES WERE REQUIRED. DERMABOND AND STERI-STRIPS WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD HOME SHARPS CONTAINER HOME SHARPS CONTAINER MMK BECTON DICKINSON NA 8254001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R