BEUDAMED
    FDA Adverse Event Summary report: N

    VANTAGE EAR IRRIGATION SYRINGE

    MDR report key: 2634270 · Received June 22, 2012

    Report

    Report Number
    MW5025980
    Date Received
    June 22, 2012
    Date of Event
    December 14, 2011
    Report Date
    March 20, 2012
    Manufacturer
    INTEGRA INC
    Product Code
    JYH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING IRRIGATION OF PT'S EAR WITH SYRINGE OF WARM WATER THE END CAP CAME OFF ITS THREADS AND IN THE PROCESS TIP WAS INSERTED INTO PT'S EAR CANAL, PIERCING HER TYMPANIC MEMBRANE. SYRINGE WAS NEARLY NEW AND THREADS HAD FAILED. DATES OF USE: (B)(6) 2011. DIAGNOSIS OR REASON FOR USE: CERUMEN IMPACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VANTAGE EAR IRRIGATION SYRINGE SYRINGE EAR SYRINGE 4 OZ JYH INTEGRA INC V919-385

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention