BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMINGTON I-LIGHT HAIR REMOVAL SYSTEM

    MDR report key: 11867106 · Received May 21, 2021

    Report

    Report Number
    3005855240-2021-00001
    Event Type
    Injury
    Date Received
    May 21, 2021
    Date of Event
    March 4, 2021
    Report Date
    May 17, 2021
    Manufacturer
    SHASER INC
    Product Code
    ONF
    PMA / PMN Number
    K140631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE IPL6780 IS NOT MARKETED FOR SALE IN THE US AND THEREFORE NOT LISTED WITH FDA. THE MODEL IS HOWEVER SIMILAR IN DESIGN AND FUNCTION AS THE IPL6800 WHICH IS LISTED UNDER 510K NUMBER K140631.

    Description of Event or Problem · 1

    CONSUMER REPORTED THAT AFTER USING THE DEVICE, SHE DEVELOPED BLISTERS ON HER FOOT AND CALF THAT REQUIRED MEDICAL TREATMENT. DR RECOMMENDED GRANUFLEX DRESSING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761806 REMINGTON I-LIGHT HAIR REMOVAL SYSTEM LUMENA ONF SHASER INC IPL6780 19112902829V

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| R