BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CT3PLUS

    MDR report key: 2577877 · Received May 10, 2012

    Report

    Report Number
    2951571-2012-00003
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    March 9, 2012
    Report Date
    May 9, 2012
    Manufacturer
    NEW STAR LASERS, INC. DBA COOLTOUCH, INC.
    Product Code
    GEX
    PMA / PMN Number
    K101783
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AFTER SURGICAL REMOVAL OF A FUNGAL TOENAIL, THE PT DEVELOPED A BONE INFECTION OF THE DISTAL PHALANX. POSSIBILITY OF INFECTION IS A KNOWN RISK FACTOR FOR NAIL REMOVAL. AMERIGEL FOR DAILY APPLICATION HAD BEEN PRESCRIBED POST-PROCEDURE. BIOPSY OF THE SKIN WAS NORMAL, AND THE PT WAS PLACED ON IV ANTIBIOTICS FOR TREATMENT OF THE INFECTION. INITIALLY THE PROBLEM WAS REPORTED IN A MANNER SUGGESTING A LASER BURN, BUT THAT WAS NOT THE CASE. THE PHYSICIAN DID NOT INDICATE ANY PROBLEMS WITH THE LASER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CT3PLUS ND: YAG SURGICAL LASER GEX NEW STAR LASERS, INC. DBA COOLTOUCH, INC. CT3PZ NA

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention