AS NEITHER A MODEL NOR A LOT NUMBER WAS PROVIDED FOR THIS INCIDENT, NO TESTS COULD BE PERFORMED ON RETAINED SAMPLES. WE HAVE REQUESTED FURTHER INFORMATION (ON THE CONCERNED PRODUCT, THE CONCERNED LOT NUMBER, THE SKIN PREPARATION, DURATION OF WEARING, TREATMENT OF THE SKIN REACTION) SEVERAL TIMES BUT WE HAVE NOT RECEIVED ANY. THE SYMPTOMS DESCRIBED INDICATE AN ALLERGIC REACTION TO ELECTRODE CONTACT. DUE TO THE LACK OF INFORMATION IT WAS NOT POSSIBLE TO FURTHER DIFFERENTIATE WHETHER IT IS A REACTION TO THE ACRYLIC ADHESIVE OF THE ADHESIVE OR TO THE GEL OF THE ELECTRODE. WE ASSUME THE INCIDENT IS RELATED TO THE PATIENTS MEDICAL CONDITION AND NOT TO A PARTICULAR ELECTRODE OR ELECTRODE BATCH AS THE PATIENT HAD STATED THAT HE HAD REACTIONS TO A NUMBER OF DIFFERENT MODELS OF ECG ELECTRODES BRANDED EITHER SKINTACT OR XLBLEU. NO FURTHER INVESTIGATION IS POSSIBLE WITHOUT THE INFORMATION NOT PROVIDED DESPITE OF REPEATED REQUESTS. WE THEREFORE CONSIDER THE INVESTIGATION CLOSED.
D
Patient 1
ON (B)(6) 2019, WE HAVE BEEN INFORMED ABOUT AN INCIDENT WITH ECG ELECTRODES (MOST LIKELY IN IRELAND), WHICH HAD HAPPENED IN 2018. MONITORING ECG ELECTRODES WERE USED. NO SPECIFIC MODEL WAS ANNOUNCED IT WAS STATED "REGARDING FANNIN SKINTACT XLBLEU AND OTHER SKINTACT ELECTRODES". IN AN ATTACHMENT OF THE INITIAL REPORTER IT WAS STATED "I HAVE REACTIONS WITH AND WITHOUT PREDNISOLONE AND THE REACTION NORMALLY STARTS WITHIN A FEW MINUTES OF HAVING THE ELECTRODE STUCK IN ME. I HAVE NO NEGATIVE REACTIONS TO PREDNISOLONE AND HAVE BEEN PRESCRIBED IT SEVERAL TIMES DUE TO ASTHMA. MY REACTION IS ALSO MORE SEVERE THAN JUST A RASH, I GET THE FOLLOWING SYMPTOMS: RASH, DIFFICULTY BREATHING MUCH LIKE AN ASTHMA ATTACK, NAUSEA, DIZZINESS". WE HAVE REQUESTED FOR FURTHER INFORMATION ON THE PATIENT, THE SKIN PREPARATION, THE PROCEDURE, THE WEARING DURATION AND HOW THE INJURIES HAD TO BE TREATED AT THE COMPLAINANT ITSELF.