BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE TRANSPARENT PFD PATCH

    MDR report key: 9596955 · Received January 16, 2020

    Report

    Report Number
    3013840437-2020-00008
    Event Type
    Injury
    Date Received
    January 16, 2020
    Date of Event
    September 27, 2019
    Report Date
    March 5, 2020
    Manufacturer
    MERZ NORTH AMERICA, INC.
    Product Code
    PKO
    PMA / PMN Number
    K150212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD FOR DESCRIBE TRANSPARENT PFD PATCH LOT 18H0359 WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NON-CONFORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 0

    FOLLOW-UP INFORMATION WAS RECEIVED ON 10-FEB-2020: THE NURSE INFORMED THAT HER EYE WAS NOT PROTECTED WITH APPROPRIATE GLASSES. THE LASER BEAM DEFLECTED TO HER LEFT EYE WHEN SHE HAD HER GLASSES OFF TO CHECK TATTOO REACTION. THE PATIENTS VISION WAS STILL LIMITED, WITH CIRCLES AND PERSISTING FLASHES. ALL WAS SLIGHTLY IMPROVED, WITH A VERY SLOW AND STEADY IMPROVEMENT. THE PATIENT WAS GOING TO WATCH AND WAIT UNTIL THE NEXT RECHECK. AS REPORTED, NO TREATMENT WAS AVAILABLE. DUE TO THE PROVIDED INFORMATION, THE OUTCOME OF CIRCLE LIKE A FLASHING SPOT IN CENTRAL AND NEAR VISION WAS CONSIDERED AS RESOLVING, AND CHANGED FROM NOT RESOLVED. THE REPORTER WAS STILL UNSURE IF THE EVENTS WERE PERMANENT. ACCORDING TO THE REPORTER, THE EVENTS WERE POSSIBLY RELATED TO THE DESCRIBE® PFD PATCH, BUT NOTED THAT THE EYE WAS NOT PROTECTED. THE REPORTER CAUSALITY WAS THEREFORE CHANGED FROM REASONABLE POSSIBILITY TO POSSIBLE.

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, CIRCLE LIKE A FLASHING SPOT IN CENTRAL VISION, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA OF NECESSITATES MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE THE DEVICE HISTORY RECORD REVIEW FOR LOT 18H0359 WILL BE SUBMITTED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS INITIALLY RECEIVED FROM A US NURSE ON 04-DEC-2019 AND CONCERNS A FEMALE PATIENT (HERSELF). FOLLOW UP INFORMATION WAS RECEIVED FROM THE NURSE ON 18-DEC-2019 AND THE CASE WAS UPGRADED TO SERIOUS. ON (B)(6) 2019, THE REPORTER WAS PERFORMING A LASER TATTOO REMOVAL USING THE DESCRIBE PFD PATCH ON A TATTOO THAT WAS QUITE FADED. SHE LOWERED HER GOGGLES AND PERFORMED A TEST SHOT WITH THE LASER. THE LASER WAS THE SPECTRA 1064 AT THE SETTING OF 3MM, 8 JOULES, AND 10 HZ. THE LASER BEAM RICOCHETED OFF OF THE PATCH AND INTO THE CENTER OF THE RETINA OF HER LEFT EYE, HITTING THE RETINA ON THE MACULA. THE MOMENT IT HIT, IT WAS LIKE A SPLATTER ON A WINDOW. THE REPORTER SAW A CIRCLE LIKE A FLASHING SPOT IN HER CENTRAL VISION. SHE CONSULTED HER COLLEAGUE, AN EMERGENCY ROOM PHYSICIAN, WHO APPLIED AN EYEDROP OF STEROIDS AND ANTIBIOTICS RIGHT AFTER THE INCIDENT AND ADVISED HER TO SEE AN EYE DOCTOR. THE PATIENT PRESENTED TO HER EYE DOCTOR ON TUESDAY, (B)(6) 2019 AND WAS REFERRED TO A RETINA SPECIALIST. THE REPORTER PRESENTED FOR TESTS ON WEDNESDAY, (B)(6) 2019. THE TESTS INCLUDED PICTURES OF THE RETINA, SPECIAL SCANS OF THE RETINA AND DIFFERENT EYE EXAMS (NAMES UNKNOWN). THE TESTS SHOWED A DIVOT IN THE RETINA AND A HEMORRHAGE. ON (B)(6) 2019, THE REPORTER SAW THE RETINA SPECIALIST AND WAS TREATED WITH A STEROID INJECTION UNDER THE LEFT EYE. THE DIVOT IN THE RETINA RESOLVED, BUT THE FLASHING CIRCLE IN HER VISION IS UNRESOLVED. THE REPORTER HAS ANOTHER APPOINTMENT WITH THE RETINA SPECIALIST IN (B)(6) 2020 AND THEY ARE CAUTIOUSLY OPTIMISTIC THAT THE EYE WILL HEAL. THE REPORTER SAID THE EYE HAS IMPROVED SINCE THE EVENT FIRST HAPPENED AND NOTED THE EVENT WAS NOT PAINFUL. SHE HAS A GOOD QUALITY OF LIFE AND CAN STILL READ AND WORK. THE REPORTER WAS UNSURE IF IT WAS THE MOISTURE IN THE PATCH WHICH CAUSED THE BEAM TO RICOCHET. SHE HAS USED THE DESCRIBE PFD PATCH BEFORE AND SAID THIS PATCH WAS NOT DIFFERENT FROM THE PREVIOUS ONES SHE HAS USED. MEDICAL HISTORY POSITIVE FOR SEVERE DRY EYE, NORMAL VISION CHANGES ASSOCIATED WITH AGING, AND BILATERAL CATARACT SURGERY. THE CATARACT SURGERY WAS PERFORMED ON EACH EYE, IN (B)(6) AND (B)(6) 2019. THE LENS IN THE LEFT EYE IS A TORQUE LENS. THE LENSES ARE STILL PERFECT FOLLOWING THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    61322 DESCRIBE TRANSPARENT PFD PATCH TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA, INC. 18H0359

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention CONCOMITANT DRUG NOT AVAILABLE