DESCRIBE PFD PATCH US
Received May 23, 2025
Report 3013840437-2025-00065 · MDR key 22078139
Device
Generic name
Transparent Patch For Use In Treatment Of Tattoos
Manufacturer
Merz North America, Inc (franksville)Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
NA · Female
- Retinal Injury
- Retinal Injury
Narrative
Additional Manufacturer Narrative
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
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.