BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M LITTMANN SELECT STETHOSCOPE

    MDR report key: 540141 · Received August 20, 2004

    Report

    Report Number
    2110898-2004-00013
    Event Type
    Injury
    Date Received
    August 20, 2004
    Date of Event
    July 17, 2004
    Report Date
    July 23, 2004
    Manufacturer
    3M HEALTH CARE
    Product Code
    IZL
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT, GOT HOLD OF THE CUSTOMER'S 3M LITTMANN SELECT STETHOSCOPE AND WAS ABLE TO REMOVE THE EARTIPS. THE PT ALLEGEDLY INSERTED THE STETHOSCOPE'S EARTHTUBES INTO THEIR EARS FAR ENOUGH TO CAUSE DAMAGE TO THEIR RIGHT EAR. THE PT WAS TREATED IN AN E.R. FOR A PERFORATED EAR DRUM AND WAS PRESCRIBED FLOXIN OTIC SOLUTION 0.3% AND CEPHALEXIN ANTIBIOTIC, 5 ML. THE CUSTOMER REPORTED THAT THE PT WAS EXAMINED BY AN EAR NOSE AND THROAT PHYSICIAN IN 2005 AND HAD SURGERY TO REPAIR THE EAR DRUM TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M LITTMANN SELECT STETHOSCOPE MANUAL STETHOSCOPE IZL 3M HEALTH CARE LITTMANN SELECT UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention