BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAX BLASTER PRO

    MDR report key: 18319404 · Received December 13, 2023

    Report

    Report Number
    3013559620-2023-00001
    Event Type
    Injury
    Date Received
    December 13, 2023
    Date of Event
    November 16, 2023
    Report Date
    December 8, 2023
    Manufacturer
    EOSERA INC
    Product Code
    KCJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EAR SYRINGING IS A COMMON CLINICAL PROCEDURE IN PRIMARY HEALTH AND THERE ARE MANY AT HOME SYRINGES AVAILABLE.

    Description of Event or Problem · 0

    PATIENT USED PRODUCT AS DIRECTED IN RIGHT EYE FIRST AND STATED THAT IT FELT AGGRESSIVE. THEN USED PRODUCT IN HIS LEFT EAR AND STATED THAT THE PRODUCT PERFORATED HIS LEFT EAR DRUM. PATIENT WENT TO URGENT CARD THE NEXT DAY. THE URGENT CARE CLEANED A WAX PACK AT THE LEFT EAR DRUM. HE SAID HE COULD NOT SEE A PERFORATION BUT THAT DID NOT MEAN THERE WASN'T A SMALL ONE. HE PRESCRIBED 500MG AMOXICILLIN SO THAT THE MIDDLE EAR DID NOT GET INFECTED AND REFERRED ME TO AN ENT SPECIALIST. PATIENT VISITED THE ENT SPECIALIST ON (B)(6)AND HE STATED THAT THE PERFORATION HAS HEALED AND TO BE VERY GENTLE WITH BOTH EARS FOR A FEW WEEKS WHILE EVERYTHING HEALS UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1655344 WAX BLASTER PRO WAX BLASTER PRO KCJ EOSERA INC WBP E223140

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male Other