BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DESCRIBE PFD PATCH US

    MDR report key: 22078139 · Received May 23, 2025

    Report

    Report Number
    3013840437-2025-00065
    Event Type
    Injury
    Date Received
    May 23, 2025
    Report Date
    May 22, 2025
    Manufacturer
    MERZ NORTH AMERICA, INC (FRANKSVILLE)
    Product Code
    PKO
    PMA / PMN Number
    K172689
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS CASE WAS ASSESSED BY MERZ NORTH AMERICA AS SERIOUS. THE EVENT OF RETINAL INJURY WAS ASSESSED AS UNEXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF DESCRIBE PFD PATCH US. STRONG CONFOUNDING FACTOR IN THIS CASE IS THE PROVIDER REMOVING PROTECTIVE GOGGLES DURING TREATMENT, AS IT IS STATED IN THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF DESCRIBE PFD PATCH TO WEAR PROTECTIVE GLOVES AND SAFETY GLASSES. NEVERTHELESS, FURTHER INFORMATION IS PENDING AND A CAUSAL RELATIONSHIP TO THE TREATMENT WITH DESCRIBE PFD PATCH CANNOT BE RULED OUT WITH CERTAINTY. CAUSALITY IS THEREFORE ASSESSED AS POSSIBLY RELATED TO THE TREATMENT WITH DESCRIBE PFD PATCH US. BASED ON THE INFORMATION PROVIDED, THIS CASE WAS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT OF RETINAL INJURY WAS DEEMED TO MEET THE SERIOUS INJURY CRITERIA OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE. MERZ CAUSALITY RE-ASSESSMENT DUE TO AMENDMENT PERFORMED ON (B)(6) 2025: EVENT LISTEDNESS HAS BEEN AMENDED FROM UNEXPECTED TO EXPECTED. THE EVENT OF RETINAL INJURY WAS ASSESSED AS EXPECTED BASED ON THE CURRENTLY VALID US INSTRUCTIONS FOR USE LEAFLET OF DESCRIBE PFD PATCH. CAUSALITY FOR THE REPORTED EVENT REMAINS UNCHANGED AS POSSIBLY RELATED TO THE TREATMENT WITH DESCRIBE PFD PATCH. BASED ON THE INFORMATION PROVIDED, THIS CASE REMAINS ASSESSED AS REPORTABLE TO THE FDA AS THE EVENT OF RETINAL INJURY WAS DEEMED TO MEET THE SERIOUS INJURY CRITERIA OF REQUIRED INTERVENTION TO PREVENT PERMANENT DAMAGE.

    Description of Event or Problem · 0

    CASE DESCRIPTION: THIS SPONTANEOUS REPORT WAS RECEIVED FROM A US PHYSICIAN AND CONCERNS A FEMALE PATIENT (ALSO THE TREATING PROVIDER). THE PROVIDER APPLIED DESCRIBE PFD PATCH US ON PATIENT FOR TATTOO REMOVAL. WHILE PERFORMING TATTOO REMOVAL, USING THE DESCRIBE PFD PATCH US APPLICATION, THE PATIENT (TREATING PROVIDER) EXPERIENCED A RETINAL BURN. THE PATIENT WAS WEARING GOGGLES AND THEN REMOVED THEIR GOGGLES DURING THE PROCEDURE. IT WAS THOUGHT THAT YAG WAVELENGTH WAS USED (AS REPORTED) AND IT BOUNCED OFF THE REFLECTIVE SURFACE OF THE DESCRIBE PFD PATCH US AND BURNED HER RETINA. THE OUTCOME OF THE EVENT WAS UNKNOWN. AMENDMENT PERFORMED ON (B)(6) 2025: LISTEDNESS AMENDED FROM UNEXPECTED TO EXPECTED BASED ON THE CURRENTLY APPROVED US INSTRUCTIONS FOR USE LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2515169 DESCRIBE PFD PATCH US TRANSPARENT PATCH FOR USE IN TREATMENT OF TATTOOS PKO MERZ NORTH AMERICA, INC (FRANKSVILLE)

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other| R