BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE TRANSPARENT PFD PATCH

    MDR report key: 9491703 · Received December 18, 2019

    Report

    Report Number
    3013840437-2019-00029
    Event Type
    Injury
    Date Received
    December 18, 2019
    Report Date
    December 18, 2019
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    PKO
    PMA / PMN Number
    K150212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, HYPERTROPHIC SCARRING, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATED MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE OF A BODY STRUCTURE AND OTHER SERIOUS IMPORTANT MEDICAL EVENT. THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED AS THE LOT NUMBER WAS NOT REPORTED.

    Description of Event or Problem · 1

    THIS CASE IS LINKED TO MDR 3013840437-2019-00026, REFERRING TO THE SAME REPORTER. THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US REGISTERED NURSE AND CONCERNS A (B)(6)-YEAR-OLD FEMALE PATIENT. THE PATIENT WAS TREATED WITH THE DESCRIBE PFD PATCH FOR TATTOO REMOVAL ON TWO AREAS, THE SUPERIOR LATERAL AREA OF THE LEFT FOOT AND THE MEDIAL UPPER INNER ARM, ABOUT SIX TO EIGHT MONTHS PRIOR TO THIS REPORT, IN 2019. THE AREA OF TREATMENT FOR THE FOOT TATTOO MEASURED 2 INCHES X 6 INCHES. THE AREA OF TREATMENT FOR THE ARM TATTOO MEASURED 4 INCHES X 6 INCHES. THE AREAS WERE TREATED WITH A Q-SWITCH 1064 LASER, USING THE LEAST AGGRESSIVE SETTINGS. SKIN TYPE OF PATIENT CLASSIFIED AS A FITZPATRICK TYPE IV. WHEN THE PATIENT LEFT THE OFFICE POST TREATMENT, THE AREAS APPEARED NORMAL, LIKE ANY OTHER TATTOO REMOVAL. THE PATIENT APPLIED AQUAPHOR TO THE AREAS, STAYED OUT OF THE SUN, AND COVERED UP. THE PATIENT RETURNED TO THE OFFICE SIX WEEKS LATER FOR RETREATMENT. A RAISED AREA OF HYPERTROPHIC SCARRING WAS PRESENT ON BOTH TREATED AREAS. CORRECTIVE TREATMENT WITH KENALOG (TRIAMCINOLONE) INJECTIONS WAS INITIATED TO ATTEMPT TO FLATTEN OUT THE AREAS, WITH SOME SUCCESS. THE HYPERTROPHIC SCARRING IS STILL PRESENT IN SOME AREAS SIX TO EIGHT MONTHS AFTER THE TATTOO REMOVAL PROCEDURE. CORRECTIVE TREATMENT WITH KENALOG INJECTIONS HAS CONTINUED, WITH THE PATIENT SCHEDULED TO RETURN FOR ANOTHER INJECTION IN (B)(6) 2019. IN THE OPINION OF THE REPORTER, THE HYPERTROPHIC SCARRING MAY BE REVERSIBLE BUT TREATMENT WAS NECESSARY TO PREVENT A PERMANENT DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1282851 DESCRIBE TRANSPARENT PFD PATCH TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other| R