BEUDAMED
    FDA Adverse Event Other Summary report: N

    3M LITTMANN MANUAL STETHOSCOPE

    MDR report key: 3472535 · Received November 4, 2013

    Report

    Report Number
    2110898-2013-00068
    Event Type
    Other
    Date Received
    November 4, 2013
    Date of Event
    November 19, 2012
    Report Date
    August 19, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    LDE
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL REPORTER NAME FROM THE FOLLOWING HOSPITAL WAS NOT PROVIDED. INFORMATION WAS OBTAINED FROM 3M HEAD OFFICE LOCATED IN (B)(4). (B)(6). ACTUAL USED DEVICE WAS NOT RETURNED. WITHOUT LOT NUMBER IT IS NOT POSSIBLE TO DETERMINE THE MANUFACTURE DATE. WITHOUT THE LOT NUMBER IT IS DIFFICULT TO DETERMINE WHAT TYPE OF EARTIPS WERE USED ON THIS SCOPE. COMPANY 3M IMPLEMENTED A CHANGE FROM THREAD TO SNAP TO MINIMIZE EARTIPS COMING OFF FROM THE STETHOSCOPE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A USER OF A STETHOSCOPE INJURED THE AREA BETWEEN HIS MIDDLE AND EXTERNAL RIGHT EAR. THE EAR TIP CAME OFF THE BINAURAL PART OF THE STETHOSCOPE. THE USER DID NOT REALIZE THIS HAD OCCURRED WHEN THE STETHOSCOPE WAS REMOVED FROM HIS POCKET AND PLACED INTO HIS EAR. REPORTEDLY THERE WAS BLEEDING WHICH WAS STOPPED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565712 3M LITTMANN MANUAL STETHOSCOPE STETHOSCOPE, MANUAL LDE 870.1875 LDE 3M HEALTH CARE NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other