BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACURIS ITE/ WAX GUARD CERU-PROTECT

    MDR report key: 3766016 · Received December 19, 2013

    Report

    Report Number
    3005019184-2013-00016
    Event Type
    Malfunction
    Date Received
    December 19, 2013
    Date of Event
    June 2, 2006
    Report Date
    December 18, 2013
    Manufacturer
    SIEMENS HEARING INSTRUMENTS, INC.
    Product Code
    ESD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED LATE BECAUSE THE INCIDENT WAS INCORRECTLY CLASSIFIED AS NOT MDR REPORTABLE. A RETROSPECTIVE REVIEW OF COMPLAINTS, HOWEVER, IDENTIFIED THIS INCIDENT AS MDR REPORTABLE. INVESTIGATION AND CONCLUSION: AN INVESTIGATION OF THE RETURNED DEVICE REVEALED THAT THE WAX GUARD EXTENDS 0.1-0.2 MM BEYOND THE CUSTOM SHELL RESULTING IN A PULL FORCE ON THE GUARD WHEN REMOVING THE INSTRUMENT FROM THE TIGHT EAR CANAL OF THIS PARTICULAR INDIVIDUAL. THIS SITUATION IS RESULTING FROM NA INCORRECT SHELL PRODUCTION. THE BORE FOR THE WAX GUARD SHOULD BE DEEP ENOUGH TO ALLOW FOR THE WAX GUARD TO BE COMPLETELY EMBEDDED IN THE ITE SHELL. AS A RESULT THE PRODUCTION PERSONNEL WAS NOTIFIED ABOUT THE INCIDENT AND INSTRUCTED HOW TO PERFORM SHELL PRODUCTION TO PROVIDE FOR A CORRECT AND TIGHT FIT OF THE CERU-PROTECT. THE PATIENT RECEIVED A REPAIRED DEVICE. THE WORK INSTRUCTION FOR THIS PRODUCTION STEP WAS UPDATED TO PROVIDE FOR A CORRECT INSTALLATION OF THE WAX GUARD AND INCLUDES THE INSTRUCTION TO VERIFY THE PROPER FIT.

    Description of Event or Problem · 1

    A PATIENT IN (B)(6) WAS WEARING HIS ACURIS ITE HEARING AID ON HIS RIGHT EAR, CONTAINING A WAX GUARD (C-GUARD). THE WAX GUARD SEPARATED FROM THE SHELL AND REMAINED IN THE PATIENT'S EAR CANAL. A HEARING HEALTH PROFESSIONAL REMOVED THE C-GUARD FORM THE PATIENT'S EAR CANAL WITHOUT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667415 ACURIS ITE/ WAX GUARD CERU-PROTECT IN THE EART HEARING AID ESD SIEMENS HEARING INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention