BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOSURE

    MDR report key: 12805627 · Received November 12, 2021

    Report

    Report Number
    1222993-2021-00044
    Event Type
    Malfunction
    Date Received
    November 12, 2021
    Date of Event
    June 23, 2021
    Report Date
    November 12, 2021
    Product Code
    GEX
    UDI-DI
    00841494100001
    PMA / PMN Number
    K210226
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLISTERS ARE AN EXPECTED TRANSIENT SIDE EFFECT. NO MEDICAL INTERVENTION WAS REPORTED. BLISTERS HAS RESOLVED. DURING A DEVICE EVALUATION, TECHNICIAN CONFIRMED THAT THE ENERGY WAS LOW AND GREATER THAN 20% OUTSIDE OF SPECIFICATION. THE DEVICE HISTORY RECORD CONFIRMS THAT THE PRODUCT PASSED AND MET ALL REQUIREMENTS BEFORE RELEASING. TECHNICIAN REPAIRED THE DEVICE. SINCE THE ENERGY WAS CONFIRMED TO BE OUTSIDE OF THE SPECIFICATION, THIS EVENT IS AN ARO (ACCIDENTAL RADIATION OCCURRENCE) AND THEREFORE REPORTABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A SECOND PATIENT EXPERIENCED BLISTERS FOLLOWING A PIGMENTATION TREATMENT USING PICOSURE. FIRST PATIENT WAS REPORTED IN MDR# 1222993-2021-00043.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1702288 PICOSURE PICOSURE GEX 100-7012-010 00841494100001

    Patients

    Seq Age Sex Outcome Treatment
    1 Female