BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE TRANSPARENT PFD PATCH

    MDR report key: 9489854 · Received December 18, 2019

    Report

    Report Number
    3013840437-2019-00026
    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, SKIN BECAME NECROTIC, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF RESULTING IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE OF A BODY STRUCTURE AND AN IMPORTANT MEDICAL EVENT DUE TO THE SEQUELAE OF HYPERTROPHIC SCARRING. 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 3013840437-2019-00029, 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 THE DORSAL AREA OF THE RIGHT HAND ABOUT ONE YEAR PRIOR TO THIS REPORT, IN 2018. THE DIAMETER OF THE TATTOO WAS DESCRIBED AS PRETTY THICK AND TOOK UP THE ENTIRE DORSAL AREA OF THE HAND. THE AREA WAS TREATED WITH EITHER A 532 LASER OR A Q-SWITCH 1064 LASER. THE REPORTER DID NOT KNOW THE SETTINGS AS HE WAS NOT THE PRACTITIONER WHO TREATED THIS PATIENT. SKIN TYPE OF PATIENT REPORTED AS EITHER A FITZPATRICK TYPE IV OR A FITZPATRICK TYPE V. THE PATIENT EXPERIENCED PROBLEMS POST TREATMENT, NOT FURTHER CLARIFIED. THE PROBLEMS PROGRESSED AND THE SKIN ON THE TREATED HAND APPEARED NECROTIC AND, FROM THERE, DEVELOPED INTO HYPERTROPHIC SCARRING, AS REPORTED. THE PATIENT HAD TEXT INTERACTIONS WITH THE TREATING PRACTITIONER DURING THIS TIME. THE PATIENT PRESENTED TO THE PRACTICE ABOUT SIX TO EIGHT MONTHS PRIOR TO THIS REPORT, IN 2019, AND THE ENTIRE CIRCUMFERENCE OF THE TREATED HAND WAS RAISED. CORRECTIVE TREATMENT REPORTED AS KENALOG (TRIAMCINOLONE) INJECTIONS EVERY SIX WEEKS. THE INJECTIONS HAVE BEEN HELPING THE MAJORITY OF THE AREA BUT ONE AREA REMAINS, DESCRIBED AS PROBLEMATIC. IN THE OPINION OF THE REPORTER, THE HYPERTROPHIC SCARRING IS PERMANENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1284192 DESCRIBE TRANSPARENT PFD PATCH TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Other| S