SKINTACT

Description of Event or Problem

ON (B)(6) 2026, WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A SKINTACT ECG ELECTRODE REF.: (B)(4) (OUR MODEL.: T.VH01.A) AT GLENROYD MEDICAL CENTRE, WHITEGATE DRIVE BLACKPOOL IN THE UK. THE INITIAL REPORTER INFORMED LEONHARD LANG ABOUT: "MY HUSBAND HAD A 48 HR HOLTER MONITOR WITH YOUR SKINTACT ELITE T-VO02 ELECTRODE. HE HAS WHAT LOOKS LIKE AN ALLERGIC REACTION TO THE CENTRE OF THE ELECTRODE, THE GREEN BIT. WOULD YOU BE ABLE TO ADVISE WHAT THAT PART CONTAINS TO HELP US UNDERSTAND WHAT HE IS ALLERGIC TO." LATER ON WE HAVE RECIEVED THE INFORMATION THAT: "WE DON'T HAVE THE PACKAGE AS THE MONITOR WAS APPLIED AT GLENROYD MEDICAL CENTRE, WHITEGATE DRIVE BLACKPOOL. I'VE ATTACHED PHOTOS BUT THEY ARE HEALED A LITTLE GIVEN THE MONITOR WAS TAKEN OFF ON SUNDAY EVENING AND THESE PHOTOS WERE TAKEN TODAY, WEDNESDAY. THE ITCHING STARTED THE EVENING THEY WERE APPLIED AND CONTINUED THROUGHOUT THE 48HRS. ONCE THE ELECTRODES WERE REMOVED THE ITCHING CONTINUED FOR ANOTHER 24 HRS EVEN WITH CREAM TO SOOTH THE ITCH. YOU CAN SEE FROM THE PHOTOS THAT IT IS MAINLY THE CENTRE OF THE ELECTRODE THAT CAUSED THE ITCH" WE HAVE RECEIVED THREE PICTURES SHOWING THE PATIENT ALLERGIC REACTION. ON THE PICTURE IT IS CLEARLY VISIBLE THAT THE ALLERGIC REACTION WAS UNDERNEATH THE GEL OF THE ECG ELECTRODE. THE PICTURE IS ALSO SHOWING A REDDISH DISCOLORATION OF THE SKIN. NO INFORMATION WAS PROVIDED ON THE CONCERNED LOT NUMBER, THE SKIN PREPARATION AND WITH WHAT THE SKIN INJURY WAS TREATED AFTERWARDS.

Additional Manufacturer Narrative

AS NEITHER A LOT NUMBER NOR SAMPLES HAVE BEEN MADE AVAILABLE TO US, NO ANALYSES COULD BE PERFORMED. THE INCIDENT IS REPORTED BECAUSE IT IS UNKNOWN HOW THE SKIN INJURY WAS TREATED IT WAS STATED "ONCE THE ELECTRODES WERE REMOVED THE ITCHING CONTINUED FOR ANOTHER 24 HRS EVEN WITH CREAM TO SOOTH THE ITCH". THE INCIDENT MIGHT NOT CONSTITUTE A REPORTABLE EVENT. WE HAVE PROVIDED THE REQUESTED INGREDIENTS LIST TO THE PATIENT INTENDED SOLELY FOR COMPARISON BY A DERMATOLOGIST TO CLARIFY ANY POTENTIAL ALLERGIES. THE PATIENT HAS RECOMMENDED THAT "TO BE CLEAR WE WERE NEVER TRYING TO PLACE BLAME BUT SIMPLY TO UNDERSTAND WHAT COULD HAVE CAUSED THE REACTION IN ORDER TO PREVENT THE DISCOMFORT FROM HAPPENING AGAIN. WE HAVE REACHED THE DESIRED OUTCOME." NO CONCLUSION REGARDING THE CAUSE OF THE "ALLERGIC REACTION" CAN BE DRAWN. WE THEREFORE CONSIDER THE INVESTIGATION AND THE REPORT TO BE CLOSED.