BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE TRANSPARENT PFD PATCH

    MDR report key: 13694582 · Received March 8, 2022

    Report

    Report Number
    3013840437-2022-00029
    Event Type
    Injury
    Date Received
    March 8, 2022
    Date of Event
    January 6, 2022
    Report Date
    March 8, 2022
    Manufacturer
    MERZ NORTH AMERICA, INC
    Product Code
    PKO
    UDI-DI
    00188295000359
    PMA / PMN Number
    K150212
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA, AS THE EVENT BLIND SPOT, WAS DEEMED TO MEET THE SERIOUS CRITERIA OF PERMANENT DAMAGE. THE DEVICE HISTORY RECORD OF DESCRIBE TRANSPARENT PFD PATCH, LOT NUMBER 21D0989, WAS REVIEWED. A LOT SEARCH WAS CONDUCTED ON THE REPORTED LOT AND NO SIMILAR EVENTS WERE NOTED. NO NONCONFORMANCE'S WERE NOTED.

    Description of Event or Problem · 0

    THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A MALE PATIENT (HIMSELF). THE PHYSICIAN USED THE DESCRIBE PFD PATCH, DURING A TREATMENT, ON (B)(6) 2022 (REPORTED AS THE PHYSICIANS DATE OF AWARENESS). BATCH NUMBER WAS REPORTED AS 21D0989 (EXPIRY DATE: 04/2024, INITIALLY REPORTED AS (21D0548). A LOT SEARCH IN THE GLOBAL SAFETY DATABASE WAS CONDUCTED. THE BATCH RECORD REVIEW WAS RECEIVED AND THE LOT NUMBER FOR DESCRIBE PFD PATCH WAS CONFIRMED AS 21D0989 (EXPIRY DATE 04/2024). ON (B)(6) 2022, DURING THE APPLICATION OF THE DESCRIBE PFD PATCH, THE PHYSICIAN DESCRIBED IT AS REFLECTIVE AND MIRROR-LIKE WHILE DEALING WITH A LASER. HE WAS WEARING GOGGLES WHEN THE PATCH REFLECTED IN HIS EYE. HE IMMEDIATELY NOTICED A SPOT IN HIS EYE WHEN THE EVENT OCCURRED AND SAID HE HAD A BLIND SPOT. THE PHYSICIAN USED THE PRODUCT MANY TIMES IN THE PAST AND THIS WAS THE FIRST TIME THIS HAPPENED. THE OUTCOME OF THE EVENT WAS UNKNOWN. FOLLOW UP INFORMATION WAS RECEIVED ON 24-FEB-2022: THIS CASE WAS UPGRADED TO SERIOUS. THE PATIENTS WEIGHT (REPORTED AS (B)(6)) WAS PROVIDED. IT WAS INITIALLY REPORTED THAT THE PATIENT WAS 45 YEARS OLD AT THE TIME OF THE EVENT. THE PATIENTS MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE REPORTED AS NONE. AT THE TIME OF TIS REPORT, NO ADDITIONAL DIAGNOSTIC TESTS WERE PERFORMED. THE PATIENT RECEIVED NO CORRECTIVE TREATMENT. THE OUTCOME OF THE EVENT REMAINED UNCHANGED. IN THE OPINION OF THE REPORTER, THE EVENT WAS PERMANENT AND RELATED TO THE DESCRIBE PFD PATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363884 DESCRIBE TRANSPARENT PFD PATCH TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA, INC 21D0989 00188295000359

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Disability CONCOMITANT DRUG NOT AVAILABLE