BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAIRMAX LASER COMB

    MDR report key: 3339324 · Received September 6, 2013

    Report

    Report Number
    MW5031744
    Event Type
    Injury
    Date Received
    September 6, 2013
    Date of Event
    January 11, 2013
    Report Date
    September 6, 2013
    Product Code
    OAP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT STARTED USING THE LASERCOMB LATE (B)(6) 2012 FOR THINNING HAIR. WITHIN 2 WEEKS SHE WAS HAVING TINGLING IN HER SCALP AND PAIN. AFTER 3 MONTHS OF PRODUCT USE SHE DISCOVERED THAT THE LASERCOMB WAS THE CAUSATIVE AGENT. SHE DISCONTINUED USE AND WITHIN 2 WEEKS THE PAIN CEASED. SHE THEN ATTEMPTED TO UTILIZE THE PRODUCT FOR A SECOND TIME. AFTER USING THE DEVICE 3 TIMES A WEEK, THE PAIN AND TINGLING RETURNED. AFTER 5 MONTHS THE PT STOPPED USING THE PRODUCT BUT CONTINUED HAVING PAIN (TREMENDOUS) AND TINGLING TO THE SCALP. THE NEUROLOGIST STATED THAT THE PAIN MAY BE PRODUCT USE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443331 HAIRMAX LASER COMB LASERCOMB OAP

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR