BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HS DSP EAR CUR LG SPOON

    MDR report key: 3445214 · Received October 28, 2013

    Report

    Report Number
    2523190-2013-00063
    Event Type
    Injury
    Date Received
    October 28, 2013
    Report Date
    October 28, 2013
    Manufacturer
    INTEGRA YORK, PA INC.
    Product Code
    JZE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    CUSTOMER INITIALLY REPORTS PATIENTS WERE SCRATCHED IN THE EAR CANAL. DREW A LITTLE BLOOD BUT NO HOSPITALIZATION WAS NEEDED. ON (B)(6) 2013, DOCTOR REPORTS SHE WAS USING DEVICE TO REMOVE EAR WAX FOR WHICH IT WAS INTENDED, CAUSING CUTS IN THE EAR CANAL MUCOSA AT A LIGHTEST TOUCH, WHEN IT IS INTRODUCED TO THE EAR CANAL. IT CAUSED EAR CANAL BLEEDING IN THE 3 PATIENTS RIGHT AWAY, BEFORE DOCTOR WAS EVEN ABLE TO GET ANY OF THE WAX OUT. NO HARM BEYOND THE SCRATCH, TREATED WITH ANTIBIOTIC DROPS X BID FOR 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551322 HS DSP EAR CUR LG SPOON M11-ENT JZE INTEGRA YORK, PA INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1