BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIERPRO

    MDR report key: 6131483 · Received November 29, 2016

    Report

    Report Number
    6131483
    Event Type
    Injury
    Date Received
    November 29, 2016
    Date of Event
    November 4, 2016
    Report Date
    November 7, 2016
    Manufacturer
    S2S GLOBAL
    Product Code
    LDE
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE EAR PIECES ARE LOOSE AND MOVE VERY FREELY UP AND DOWN THE METAL SHAFTS ALONG WITH SPINNING AROUND THE SHAFTS. IN ONE INSTANCE, A HEALTH CARE PROVIDER SUFFERED A PERFORATED EARDRUM AS A RESULT OF THE METAL SHAFT PENETRATING THROUGH THE EAR PIECE AND INTO HER EAR CANAL. MANUFACTURER RESPONSE FOR DISPOSABLE STETHOSCOPE, DUAL HEAD DISPOSABLE STETHOSCOPE (YELLOW) (PER SITE REPORTER): THE MANUFACTURER SHIPPED IN DIFFERENT LOT NUMBERS OF OLDER MANUFACTURING DATES. OTHERWISE, DIALOGUE CONTINUES BETWEEN OUR FACILITY AND THE MANUFACTURER TO DETERMINE A ROOT CAUSE OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    783861 PREMIERPRO STETHOSCOPE, MANUAL LDE S2S GLOBAL CASF07-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R NO