BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREMIER PRO 6380 STETHOSCOPE

    MDR report key: 6358186 · Received February 24, 2017

    Report

    Report Number
    3007304336-2017-00001
    Event Type
    Injury
    Date Received
    February 24, 2017
    Date of Event
    November 4, 2016
    Report Date
    February 17, 2017
    Manufacturer
    IMEDIPLUS INC.
    Product Code
    LDE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A USER OF THE PREMIER PRO 6380 STETHOSCOPE SUFFERED A SCRATCHED EAR WHEN USING THE DEVICE. IT WAS REPORTED THAT THE EAR PIECES (TIPS) ON THE EAR TUBE BECAME LOOSE AND ALLOWED ENDS OF THE TUBE TO SCRATCH THE EAR. IT WAS REPORTED TO S2S GLOBAL THAT THE USER WENT TO THE INJURY CLINIC AND THE CLINIC CONFIRMED AN EAR ABRASION. THERE WAS NO REPORT OF DAMAGE TO THE EAR DRUM. S2S GLOBAL FOLLOWED UP WITH THE ACCOUNT THAT REPORTED THE INCIDENT ON (B)(6) 2016 AND ON DECEMBER 20, 2016 (B)(6) RESPONDED THAT THE PATIENT HAD FULLY RECOVERED AND THAT THERE WAS NO FURTHER EXAMINATION OF THE PATIENT OTHER THAN THE INITIAL ASSESSMENT. WE ARE NOT ABLE TO CONFIRM THE USER SUFFERING A PUNCTURED EAR DRUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139086 PREMIER PRO 6380 STETHOSCOPE STETHOSCOPE LDE IMEDIPLUS INC. 6380 CASF 07-01

    Patients

    Seq Age Sex Outcome Treatment
    1 Other