BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACNE HEALING PATCH, MICRONEEDLE TECHNOLOGY

    MDR report key: 8912703 · Received August 19, 2019

    Report

    Report Number
    MW5089203
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    August 12, 2019
    Report Date
    August 12, 2019
    Manufacturer
    RAEL, INC.
    Product Code
    NAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PRODUCT WAS PURCHASED THROUGH (B)(6). THE PRODUCT SHOWS A HEALTH CLAIM ON THE FRONT PACKAGE "ACNE HEALING PATCH". IT INCLUDES SALICYLIC ACID, BUT DOESN'T HAVE ANY DOSAGE OR WARNING OR ANY TYPE OF DIRECTION. THE PATCH WAS FOR ACNE AND THE PATCH HAD A MICRONEEDLE. IT ALSO SAYS "HEAL" ON THE BACKSIDE OF THE PACKAGE WHICH MAKES US ASSUME THIS IS SOME TYPE OF DRUG PRODUCT. HOWEVER, IT DOESN'T PROPERLY SHOW ACTIVE INGREDIENT OR ANY OTHER INFORMATION. I AM WORRIED IF THE TEENAGERS PURCHASE THE PRODUCT MIGHT HAVE THE SIDE EFFECTS DEPENDS ON THEIR CONDITION. ALSO, I WAS WORRIED IF THAT MIGHT CAUSE SECOND HAD AN INFECTION OR INTRODUCING BACTERIA THROUGH THE SKIN. I WOULD LIKE THE COMPANY TO PROPERLY REGISTER OR UPDATE THEIR PACKAGE BY THE FDA REGULATION. ACNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698829 ACNE HEALING PATCH, MICRONEEDLE TECHNOLOGY DRESSING, WOUND, HYDROPHILIC NAC RAEL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Other