BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INPULSE LASER

    MDR report key: 1359146 · Received April 9, 2009

    Report

    Report Number
    2954939-2009-00001
    Event Type
    Injury
    Date Received
    April 9, 2009
    Date of Event
    February 28, 2009
    Report Date
    March 31, 2009
    Manufacturer
    INCISIVE, INC.
    Product Code
    GEX
    PMA / PMN Number
    K011423
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE CONCLUSIONS ARE THAT THE DOCTOR DID NOT FOLLOW THE RECOMMENDATIONS OF THE TRAINING, WAS NOT SUFFICIENTLY AWARE OF THE RISKS OF APPLYING EXCESSIVE AMOUNTS OF LASER ENERGY, AND DID NOT RESPOND APPROPRIATELY TO THE SYMPTOM OF PAIN DURING THE PROCEDURE. THE MANUFACTURER HAS INITIATED A CORRECTIVE ACTION TO PREVENT THE RECURRENCE OF SUCH AN EVENT AS FOLLOWS: THE OPERATOR'S MANUAL HAS BEEN REVISED TO INCLUDE THE RISKS OF THERMAL INJURY. THE TRAINING DOCUMENTS HAVE BEEN REVISED TO INCLUDE THE FOLLOWING: DETAILED DISCUSSION OF PROPER DOSIMETRY; EFFECTS OF CHANGES IN ENERGY DENSITY OF APPLIED LASER ENERGY; UNDERSTANDING OF PROPER RESPONSE TO PATIENT SENSATION OF PAIN; INSTRUCTION ON USE OF ANESTHETIC. THE DOCTOR HAS BEEN RE-TRAINED PER THE NEW TRAINING DOCUMENTS. SEE SCANNED PAGES.

    Description of Event or Problem · 1

    DOCTOR TREATED PATIENT WITH LASER TO KILL FUNGUS SHOWING IN THE THUMB NAIL. DOCTOR REPORTED THAT HE APPLIED CONSIDERABLE AMOUNT OF LASER ENERGY, BECAUSE HE WANTED TO BE SURE HE DESTROYED ALL OF THE FUNGUS, AND BECAUSE HE BELIEVED THAT NO HARM WOULD ENSUE. WHEN PATIENT REPORTED FEELING PAIN, DOCTOR PERFORMED PAIN BLOCK, AND CONTINUED THE PROCEDURE. PROCEDURE WAS PERFORMED IN 2009. ABOUT 2 DAYS POST-PROCEDURE, PATIENT REPORTED THAT HE HAD EXPERIENCED CONSIDERABLE POST-OPERATIVE SWELLING AND PAIN, AND THAT HE (THE PATIENT) HAD DRILLED 3 HOLES THROUGH THE THUMB NAIL TO RELIEVE THE PRESSURE. THE DOCTOR EXAMINED PHOTOGRAPHS TAKEN BY THE PATIENT AND CONCLUDED THAT THERE HAD BEEN CONSIDERABLE THERMAL INJURY. DOCTOR ADVISED PALLIATIVE TREATMENT, PRESCRIBED AN OINTMENT FOR TOPICAL APPLICATION TWICE PER DAY AND THE USE OF IBUPROFEN AS NEEDED. DOCTOR ADVISED THAT MOST LIKELY OUTCOME WAS COMPLETE HEALING. PATIENT REPORTED CONTINUED NUMBNESS AND PAIN. AFTER APPROXIMATELY TWO WEEKS, PATIENT REPORTED APPARENT INFECTION IN THE THERMALLY INJURED AREA. PATIENT HAD VISITED HIS REGULAR PHYSICIAN WHO PRESCRIBED AN ANTIBIOTIC. DOCTOR RECOMMENDED THE PATIENT RETURN FOR FURTHER TREATMENT (INTERVENTION). DOCTOR REMOVED THE THUMB NAIL, REMOVED THE NECROTIC TISSUE IN THE AREA, AND RECOMMENDED CONTINUED USE OF THE SYSTEMIC ANTIBIOTIC, AS WELL AS THE TOPICAL SILVERADAZINE AND NEOSPORIN. DOCTOR REPORTED THAT THE NAIL MATRIX APPEARED VITAL WITH GOOD BLOOD SUPPLY, AND HIS OPINION WAS THAT MOST LIKELY THE PATIENT WOULD HAVE A FULL RECOVERY, THAT IS, THAT THE NAIL WOULD REGROW NORMALLY. HOWEVER, IT WAS NOT CERTAIN AND THERE WAS SOME CHANCE THAT THE NAIL RE-GROWTH WOULD BE DISTORTED, OR A SMALL POSSIBILITY THAT THE NAIL WOULD NOT REGROW AND BE LOST. DOCTOR STATED THAT IT WOULD BE APPROXIMATELY 3 MONTHS TO DETERMINE THE OUTCOME. AT ABOUT ONE WEEK LATER, PATIENT REPORTED THAT THE INFECTION APPEARED TO BE GONE, AND THAT THE SKIN LOOKED HEALTHY. HOWEVER, SOME PAIN AND NUMBNESS REMAIN. THAT IS THE MOST RECENT REPORT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INPULSE LASER GEX INCISIVE, INC. INPULSE

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention