BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM

    MDR report key: 24807896 · Received April 7, 2026

    Report

    Report Number
    3031944951-2026-00003
    Event Type
    Injury
    Date Received
    April 7, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 7, 2026
    Manufacturer
    ROHRER AESTHETICS, INC.
    Product Code
    GEX
    UDI-DI
    00086056400031
    PMA / PMN Number
    K123777
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    ROHRER AESTHETICS HAS MADE 4 ATTEMPTS TO PROVIDER TO OBTAIN PATIENT HEALING STATUS AND TO FURTHER EVALUATE TREATMENT PARAMETERS AND TECHNIQUES WITH NO RESPONSE. ROHRER AESTHETICS WILL TREND AND TRACK ADVERSE EVENTS OF A SIMILAR NATURE. ROHRER AESTHETICS WILL REOPEN CASE IF PROVIDER COMMUNICATES WITH ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    PATIENT RECEIVED HER FIRST TREATMENT FOR BIKINI LASER HAIR REMOVAL WITH SPECTRUM 810 DIODE LASER ON (B)(6) 2026. AFTER TREATMENT WAS DONE PATIENT SENT A PICTURE OF DARKENED SPOT IN THE BIKINI AREA TO PROVIDER ANDTHEY ADVISED APPLYING AQUAPHOR OR VASELINE AND REQUESTED SHE CALL BACK WITH ANY CONCERNS. (B)(6) PATIENT NOTIFIED PROIDER THAT SHE VISITED HER PCP AND URGENT CARE ON (B)(6) 2026 DUE TO AN OPEN LESION IN THE BIKINI AREA. PATIENT DENIED EXCESSIVE SUN EXPOSURE ON A TRIP TO (B)(6) OR ANY AGGRESSIVE MANIPULATION OF THE LESIONS. (B)(6) 2026 URGENT CARE NOTES INDICATE "FULL THICKNESS BURN OF GROIN DUE TO LASER HAIR REMOVAL, LIKELY DUE TO INAPPROPRIATE LASER SETTINGS. NO CURRENT INFECTION AND EXPECTED PROLONGED HEALING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33519 SPECTRUM POWERED LASER SURGICAL INSTRUMENT GEX ROHRER AESTHETICS, INC. SPECTRUM 00086056400031

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention