inforMED
MalfunctionMWJ

BIOTEL HOLTER MONITOR

Received Aug 7, 2025 · Event occurred Dec 15, 2023

Report 22737635 · MDR key 22737635

Device

Generic name

Electrocardiograph, Ambulatory (without Analysis)

Product problems

  • Patient-Device Incompatibility
  • Excessive Heating

Patient

11 YR · Female

  • Erythema
  • Itching Sensation
  • Impaired Healing
  • Superficial (First Degree) Burn
  • Erythema
  • Itching Sensation
  • Impaired Healing
  • Superficial (First Degree) Burn

Narrative

Description of Event or Problem

THE PATIENT WORE BIOTEL HOLTER MONITOR FROM [DATE REDACTED] TO [DATE REDACTED] - APPROXIMATELY 7 DAYS, AND SUSTAINED A LEFT SIDE BURN ON THE CHEST. PATIENT¿S MOTHER INFORMED STAFF IN FOLLOW UP CALL SHE WOULD LET THE BURN ¿BREATHE¿ AND PATIENT INDICATED THE BURN ITCHED. PATIENT HOLTER MONITOR PLACED AGAIN ON [DATE REDACTED], INSTRUCTED TO WEAR 7 DAYS. PATIENT WAS SEEN AS FOLLOW UP ON [DATE REDACTED] IN CARDIOLOGY TO REVIEW HOLTER MONITOR RESULTS. NO NOTED DISCUSSION WITH PROVIDER ON [DATE REDACTED] REGARDING BURN FROM MONITOR FROM [DATES REDACTED]-TIME FRAME. AT THE [DATE REDACTED] VISIT, THE EKG [ELECTROCARDIOGRAM] TECH NOTICED A RED AREA ON PATIENT¿S CHEST, ASKED MOM ABOUT IT. MOM STATED SHE THOUGHT THAT IT WAS A BURN REMOVED THE HOLTER AFTER 6 DAYS HOPING THAT THE AIR WOULD HELP TO HEAL THE AREA. PROVIDER NOTIFIED OF THE AREA AND CONCERN FOR BURN. PROVIDER NOT CONCERNED AT TIME OF [DATE REDACTED] APPOINTMENT. UPDATE ON [DATE REDACTED], PATIENT IS DOING FINE. WE FOLLOWED UP WITH PATIENT¿S MOTHER YESTERDAY [DATE REDACTED], ASKING HOW THE AFFECTED AREA LOOKED AND WAS THERE ANY FURTHER IRRITATION. MOM REPORTS AREA IS HEALED, SOMETIMES ITCHY FOR PATIENT. PATIENT¿S MOTHER WAS ASKED TO SEND DOCUMENTATION OF THE AREA THROUGH THE PATIENT PORTAL FOR RECORDS. PATIENT¿S MOTHER SENT THIS LATE YESTERDAY AFTERNOON. CONFIRMED THIS MORNING INFORMATION UPLOADED. NO OPEN WOUND. APPEARS SLIGHTLY BROWNISH/RED IN COLOR. PATIENT IS TO HAVE ANOTHER HOLTER DEVICE ORDERED AND WE HAVE SHARED WITH MOM THAT SENSITIVE STICKERS FOR HOLTER PLACEMENT WOULD BE SENT TO THE FAMILY.