BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCWAX BLASTER MD

    MDR report key: 10837438 · Received November 13, 2020

    Report

    Report Number
    3013559620-2020-00001
    Event Type
    Injury
    Date Received
    November 13, 2020
    Date of Event
    October 5, 2020
    Report Date
    November 13, 2020
    Manufacturer
    EOSERA INC
    Product Code
    OGQ
    UDI-DI
    00851722007095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EAR SYRINGING IS A COMMON CLINICAL PROCEDURE IN PRIMARY HEALTH CARE AND THERE ARE MANY 'AT-HOME' SYRINGES AVAILABLE. IN THIS CASE, THE CUSTOMER STATED THAT HIS DOCTORS OFFICE RECOMMENDED THAT HE PURCHASE AN EAR IRRIGATING DEVICE TO USE AT HOME. WE HAVE NOT BEEN SUCCESSFUL IN OBTAINING ANY OTHER ADDITIONAL INFORMATION FROM THE CUSTOMER ON THE EVENT AFTER 3 ATTEMPTS. WE HAVE HAD NO OTHER REPORTABLE COMPLAINTS ON THIS PRODUCT. THE DATE OF THIS REPORT IS PAST THE 30 DAY REQUIREMENT. DURING OUR ATTEMPT TO GET FULL PRODUCTION ACCESS TO WEBTRADER.COM, WE FOUND OUT THAT WEBTRADER DOES NOT SUPPORT (B)(6) COMPUTERS, WHICH WAS OUR PRIMARY PLATFORM. IT TOOK ADDITIONAL TIME FOR US TO GAIN ACCESS TO A PC. TODAY (11/13/2020) WE RECEIVED FULL PRODUCTION ACCESS FROM THE ESG HELPDESK TEAM. OUT OF ABUNDANCE OF CAUTION, WE PHYSICALLY MAILED THE FORM 3500A TO THE FOLLOWING ADDRESS ON 11/5/2020: (B)(6).

    Description of Event or Problem · 1

    FATHER USED EAR RINSE DEVICE ON SON TO CLEAR EAR CANAL AS DIRECTED BY THEIR PHYSICIAN. FATHER REPORTED THAT THE EAR DRUM RUPTURED DURING USE. THE NEXT DAY HE TOOK THE CHILD TO URGENT CARE AND THE CHILD HAD A RUPTURED EAR DRUM CONFIRMED BY URGENT CARE DOCTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1299486 OCWAX BLASTER MD EAR RINSE SYSTEM OGQ EOSERA INC X203014 00851722007095

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR Other