BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE TRANSPARENT PFD PATCH

    MDR report key: 7911702 · Received September 26, 2018

    Report

    Report Number
    3013840437-2018-00001
    Event Type
    Injury
    Date Received
    September 26, 2018
    Date of Event
    August 7, 2018
    Report Date
    September 26, 2018
    Manufacturer
    MERZ NORTH AMERICA
    Product Code
    PKO
    UDI-DI
    00186295000359
    PMA / PMN Number
    K150212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT, PERMANENT SCAR, WAS DEEMED TO MEET SERIOUS INJURY CRITERIA. THE DEVICE HISTORY RECORD FOR DESCRIBE TRANSPARENT PFD PATCH LOT 17F097 WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NON-CONCORMANCES WERE NOTED THAT WOULD HAVE CONTRIBUTED TO THIS EVENT.

    Description of Event or Problem · 1

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A REGISTERED NURSE AT A LASER CENTER AND CONCERNS A FEMALE PATIENT WHO IS A TECHNICIAN AT THE OFFICE WHO WAS USING A LASER AND THE DESCRIBE PATCH ON (B)(6) 2018. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS NOT REPORTED. DURING THE PROCEDURE, THE TECHNICIAN REMOVED HER GOGGLES AND PERFORMED THE LAST LASER PASS WITHOUT THEM. SHE COULD NOT SEE CLEARLY AND NOTED SOME TYPE OF REFLECTION OFF OF THE PATCH. SHE WAS SEEING DARK SPOTS. THE PATIENT PRESENTED TO AN OPHTHALMOLOGIST (ALSO REPORTED AS AN OPTOMETRIST) FOR EVALUATION. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER VIA TELEPHONE ON (B)(6) 2018: THE PATIENT HAS CONTINUED TO SEE A RETINA SPECIALIST. HER SYMPTOMS ARE IMPROVING WITH TIME. FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER VIA FAX ON (B)(6) 2018: THE PATIENT'S INITIALS AND AGE WERE PROVIDED. MEDICAL HISTORY REPORTED AS NEGATIVE. PATIENT IS A FITZPATRICK SKIN TYPE II. THE (B)(6) -YEAR-OLD PATIENT/LASER TECHNICIAN REMOVED HER GOGGLES DURING A TATTOO REMOVAL PROCEDURE TO OBSERVE A PULSE THROUGH THE DESCRIBE PFD PATCH, WHICH WAS BEING USED WITH A Q SWITCH LASER. SHE FELT A "POP" IN HER EYE (SIDE NOT SPECIFIED) AND, SHORTLY THEREAFTER, DEVELOPED BLURRY AND FOGGY VISION. THE PATIENT HAD AN EYE EXAM (NOT FURTHER SPECIFIED), WHICH CONFIRMED LASER IMPACT TO THE RETINA IN THE FOVEAL REGION OF THE EYE. PER THE REPORTER, THE LASER IMPACT WOULD HAVE TO BE FROM REFLECTION FROM THE PATCH SURFACE. AT NO TIME WAS THE LASER AIMED AT THE EYE AND NO DIRECT IMPACT TO THE EYE OCCURRED. THE LASER ONLY TARGETED THE TATTOO AND PATCH ON THE PATIENT BEING TREATED AT THE TIME. LOT NUMBER REPORTED AS 17F0497. TREATMENT REPORTED AS NONE. CAUSALITY REPORTED AS "UNSURE BUT HIGHLY SUSPICIOUS OF ROLE PATCH PLAYED IN INJURY." FOLLOW UP INFORMATION WAS RECEIVED FROM THE REPORTER VIA TELEPHONE ON (B)(6) 2018: MEDICAL HISTORY NEGATIVE FOR ABNORMAL VISION OR THE NEED FOR VISUAL AIDS SUCH AS READING GLASSES. IT IS UNKNOWN IF THE DESCRIBE PFD PATCH WAS WAVY OR OTHERWISE CHANGED AT THE TIME OF USE. THE PATIENT/LASER TECHNICIAN REMOVED HER GOGGLES DURING THE PROCEDURE TO "GET A BETTER LOOK" AT THE PROCEDURE SITE, BECAUSE SHE HAD DIFFICULTY SEEING IT THROUGH THE PATCH WITH THE GOGGLES ON AND PERFORMED THE LAST PASS. THE PATIENT/LASER TECHNICIAN FELT THE IMPACT OF THE LASER. IT HAPPENED VERY QUICKLY, LIKE A CAMERA FLASH (NOT A SPARK). SHE BLINKED MULTIPLE TIMES BUT COULD NOT ADJUST HER VISION AND WAS SEEING SPOTS. THE PATIENT SAW AN OPTOMETRIST, THEN A RETINAL SPECIALIST. DURING EXAM, "THERE WAS A HEMORRHAGE AND THERE IS A LITTLE SCAR". THE REPORTER DID NOT KNOW THE EXACT ANATOMY/LOCATION OF THESE. THE SCAR IS PERMANENT. TREATMENT REPORTED AS NONE. THE PATIENT/LASER TECHNICIAN CONTINUES TO HAVE BLURRY VISION AND HAS BEEN WEARING READING GLASSES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    751708 DESCRIBE TRANSPARENT PFD PATCH TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA 5035837 17F0497 00186295000359

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR