BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HYDRAFACIAL

    MDR report key: 3108813 · Received May 6, 2013

    Report

    Report Number
    2031227-2013-00001
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    July 27, 2010
    Report Date
    May 6, 2013
    Manufacturer
    EDGE SYSTEMS LLC
    Product Code
    GFE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT OCCURRED IN 2010, BUT WAS NOT BROUGHT TO EDGE SYSTEMS' (MANUFACTURER) ATTENTION UNTIL RECENTLY BY THE LAWSUIT BETWEEN THE CONSUMER AND THE HEALTH PROFESSIONAL. THE ATTORNEY PROVIDED MEDICAL RECORDS AND DETAILS ON (B)(6) 2013, SO EDGE SYSTEMS WAS ABLE TO FILE A REPORT. THE INCIDENT WAS CAUSED BY OPERATOR NEGLECTING TO FOLLOW THE INSTRUCTIONS FOR USE (IFU). IT WAS OPERATOR ERROR; NO DEVICE MALFUNCTION OR PRODUCT DEFECTS. THE SUSPECT COSMETIC PRODUCT(S) USED IN CONJUNCTION WITH THE DEVICE CONTAIN GLYCOLIC ACID AND SALICYLIC ACID AT LOW CONCENTRATION THAT ARE SAFE TO USE ON HUMAN SKIN SURFACE TO REMOVE STRATUM CORNEUM IF THE RECOMMEND INSTRUCTIONS FOR USE ARE FOLLOWED PROPERLY. THE SUSPECT PRODUCT(S) ARE NOT INTENDED TO BE USED ON OR AROUND THE EYES. THE IFU PROVIDED BY EDGE SYSTEMS, INCLUDING USE MANUALS, TRAINING DVDS, AND LABELS, PROVIDE ADEQUATE AND PROPER INSTRUCTIONS AND RECOMMEND THE USE OF EYE PROTECTION FOR PATIENT DURING TREATMENT. THE IFU ALSO STATE THAT IF THE FLUIDS GET INTO THE EYES, RINSE WITH WATER IMMEDIATELY, AND SEEK MEDICAL CARE IF IRRITATION OCCURS/PERSISTS. EDGE SYSTEMS ALSO PROVIDED TRAINING TO THE HEALTH PROFESSIONAL AT TIME OF DEVICE PURCHASE, EDUCATING OPERATORS THE PROPER TREATMENT PROTOCOLS AND PROCEDURES. IN ADDITION, ALL THE LOTS OF SUSPECT PRODUCT(S) THAT COULD POSSIBLY BE USE AROUND THE DATE OF EVENT ALL SHOWED COMPLIANCE TO SPECIFICATIONS AND NO MICROBIAL GROWTH OR DEFECTS WERE FOUND.

    Description of Event or Problem · 1

    PATIENT RECEIVED A FACIAL ACID PEEL (COSMETIC TREATMENT) PERFORMED BY THE HEALTH PROFESSIONAL DURING THE ABOVE DATES. THE SUSPECT PRODUCTS USED WERE COSMETIC PRODUCTS CONTAINING GLYCOLIC ACID AND SALICYLIC ACID; THE PRODUCTS WERE USED IN CONJUNCTION WITH THE HYDRAFACIAL WAVE DEVICE. THE OPERATOR FAILED TO FOLLOW INSTRUCTIONS FOR USE AND PRECAUTION TO PROPERLY COVER AND PROTECT PATIENT'S EYES DURING FACIAL TREATMENT, CAUSING THE ACIDIC FLUIDS TO GET INTO PATIENT'S EYES AND SURROUNDING AREAS, RESULTING IN REPORTED PATIENT INJURIES. THOSE REPORTS INCLUDE EXCESSIVE TEARING OF BOTH EYES; ITCHINESS, SWELLING, AND BURNING SENSATION OF THE EYES AND SURROUNDING AREAS; RASH AN IRRITATED SKIN; MILD CONTACT DERMATITIS; LACRIMAL TEAR DUCT STENOSIS; MILD SINUSITIS WITH NASAL OBSTRUCTION; MILD PERIORBITAL CELLULITIS, ETC. PATIENT ALSO COMPLAINED ABOUT BLURRY VISION, SENSITIVE TO LIGHT, ETC. PATIENT WAS CAUSED TO USE EYE DROPS, FACIAL OINTMENTS, WARM COMPRESSES, MEDICATIONS, AND UNDERWENT A BILATERAL LOWER EYELID PUNCTOPLASTY. PATIENT WAS NOT HOSPITALIZED OR CONFINED TO BED, BUT WAS CONFINED TO HER HOME FOR APPROXIMATELY 30 DAYS INTERMITTENTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196062 HYDRAFACIAL GFE, HYDRADERMABRASION GFE EDGE SYSTEMS LLC HYDRAFACIAL WAVE

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention GLYSAL PEEL| 1.5% SALICYLIC ACID| GLYSAL PREP, 7.5%| 15% GLYCOLIC ACID| SLICYLIC ACID| GLYCOLIC ACID AND 2%