BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EAR CANDLING

    MDR report key: 2462538 · Received February 14, 2012

    Report

    Report Number
    MW5024269
    Event Type
    Injury
    Date Received
    February 14, 2012
    Date of Event
    February 1, 2012
    Report Date
    February 14, 2012
    Manufacturer
    WHITE SANDS SALON AND DAY SPA
    Product Code
    JYH
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    A "FRIEND" WHO WORKS AT THE (B)(6) SALON AND DAY SPA IN (B)(6) SUGGESTED AN EAR CANDLING SERVICE. ON (B)(6) 2012, (B)(6) PERFORMED EAR CANDLING. ON (B)(6) 2012, I HAD SEVERE EAR PAIN AND IT WAS REPORTED TO A SALON EMPLOYEE WHICH WENT IGNORED. ON (B)(6) 2012, MY PAIN LEVEL INCREASED TO A 10 OUT OF 10, I HAD HEARING IMPAIRMENT AS WELL AS A FLUID LEAKAGE. THE URGENT CARE DOCTOR DIAGNOSED ME WITH RUPTURED EAR DRUM CAPILLARIES, "BRUISING" OF THE EAR DRUM, WITH A POSSIBLE SECONDARY INFECTION OF MASTOIDITIS AS A RESULT OF TRAUMA TO THE INNER EAR. ON (B)(6) 2012, I CONTACTED THE SALON OWNER, (B)(6), TO INFORM HER OF THE RESULT OF MY TREATMENT AT HER SALON. (B)(6) HAS YET TO RETURN MY CALL. ON (B)(6) 2012, MY SYMPTOMS HAVE NOT RESOLVED AND IN SOME ASPECTS WORSENED, SO I SOUGHT FURTHER CARE FROM THE (B)(6) EAR ASSOCIATES. MORE IN DEPTH ANALYSIS OF MY EAR STRUCTURES AND FUNCTION WERE PERFORMED. THE RESULT WAS A DIAGNOSIS OF: RUPTURING OF EAR DRUM CAPILLARIES AND A FIRST DEGREE BURN. MY EAR PAIN IS A CONSISTENT 8 OUT OF 10 AND MY HEARING DIFFICULTIES CONTINUE. IT FEELS LIKE MY EAR IS "UNDERWATER." I STILL HAVE YET TO HEAR BACK FROM THE SALON IN TERMS OF ACKNOWLEDGING MY CONDITION AS A RESULT OF THE TREATMENT RECEIVED. (B)(6) SALON AND DAY SPA, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAR CANDLING EAR CANDLE JYH WHITE SANDS SALON AND DAY SPA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Disability