Universal electrode-patch 02-01609Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI B146PE20), received between Nov 18, 2022 and Sep 24, 2026 — classified as 22 injuries.

The most frequently reported specific device problem is “Biocompatibility” (18 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2026Biocompatibility

  It was reported on (b)(6) 2026 that the patient was experiencing skin irritation while wearing the Electrode - Adapter - Lead Wire with Electrode - Pad - Foam - Vermed A10091. The patient described experiencing general redness and red bumps where the patch was applied. The patient did seek medical attention and was prescribed a topical steroid. The patient took a break in service due to the skin irritation. The patient did follow the recommended skin preparation. The patient had a history of skin sensitivity and allergy to latex. No further information to provide.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 50882702 ↗
• InjurySep 22, 2026Biocompatibility

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 50859366 ↗
• InjuryApr 2, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED ON (B)(6) 2025, THAT THE PATIENT HAS DEVELOPED A RASH FROM THE MCOT SENSOR - 3.0 AND ELECTRODE - PATCH - UNIVERSAL 2 CHANNELS. THE PATIENT'S MOTHER INDICATED THAT HE PATIENT'S SKIN IS SO IRRITATED IT IS BLEEDING AND HURTING. THE PATIENT'S MOTHER CONSULTED WITH THE CARE TEAM THROUGH MYCHART. THE PATIENT TOOK BREAKS WEARING THE DEVICE WHEN THE MCOT SENSOR - 3.0 WAS CHARGING AND WOULD PLACE OINTMENT ON THE SKIN. ON (B)(6) 2025, THE PATIENT'S MOTHER REMOVED THE MCOT SENSOR - 3.0 DUE IT GETTING SO HOT THE PATIENT COULD NO LONGER WEAR IT. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE OBTAINED.

  Patient problems: Burn(s); Hemorrhage/Blood Loss/Bleeding; Skin Burning Sensation; Skin Inflammation/ Irritation

  MAUDE report 21752403 ↗
• InjuryFeb 24, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED ON 03 FEBRUARY 2025 THAT ON (B)(6) 2025 WHEN THE PATIENT'S MOTHER WAS REMOVING THE EPATCH SENSOR - 2.5 AND ELECTRODE - PATCH - UNIVERSAL 2 CHANNEL IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING RAW AND BUMPY SKIN IRRITATIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 06 FEBRUARY 2025 THAT REPORTED THAT THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED TRIAMCINOLONE ACETONIDE .25%. IT WAS NOTED THAT THE DEVICE WAS ORIGINALLY PLACED AT THE PATIENT'S DOCTOR'S OFFICE AND THAT THE PATIENT HAD EXPERIENCED SKIN SENSITIVITIES FROM BANDAGE AND BRACE. THE PATIENT'S SYMPTOMS DID IMPROVE AFTER REMOVE THE DEVICE. THE PATIENT WAS ALSO SENT ALTERNATIVE ELECTRODES TO COMPLETE SERVICE.

  Patient problems: Rash; Skin Inflammation/ Irritation

  MAUDE report 21446883 ↗
• InjuryFeb 19, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED ON 23 JANUARY 2025 THAT ON (B)(6) 2025 THE PATIENT WAS EXPERIENCING SEVERE SKIN IRRITATION. THE PATIENT REPORTED THAT THEY STARTED WITH REGULAR CHEST PATCH APPLICATION WHICH IS WHAT CAUSED THE SERIOUS SKIN IRRITATION WHICH WAS BLEEDING AT REMOVAL. THE PATIENT REPORTED THAT THEY SWITCHED TO FLEX ADAPTER WHICH RESULTED IN EVEN WORSE SKIN INITIATION ACCOMPANIED BY BLEEDING. THE PATIENT FOLLOWED UP ON 22 JANUARY 2025 WITH ADDITIONAL INFORMATION AND THE FOLLOWING WAS REPORTED, THE PATIENT DID SEEK MEDICAL ATTENTION AND WAS ADVISED TO TAKE A BREAK IN SERVICE AND MOVE THE PLACEMENT OF THE ELECTRODES TO A DIFFERENT SPOT TO AVOID FURTHER IRRITATION HOWEVER, THE PATIENT NOTED THAT DID NOT WORK. THE PATIENT ALSO USED OVER THE COUNTER (OTC) ANTIBACTERIAL AND ANTIFUNGAL TOPICAL MEDICATION AND CONTINUED WITH SERVICE HOWEVER, THE DISCOMFORT FROM THE SKIN IRRITATION BECAUSE UNBEARABLE. THE PATIENT REPORTED THAT THEY STARTED EXPERIENCING ITCHING AND BURNING SENSATION THAT WOULD WAKE THE PATIENT UP IN THE MIDDLE OF THE NIGHT. THE PATIENT STOPPED MONITORING ON AN UNKNOWN DATE DUE THE BLEEDING AND SKIN PUSTULES. THE PATIENT REPORTED THAT THEY FOLLOWED SKIN PREP BY WASHING SKIN WITH OIL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Skin Inflammation/ Irritation

  MAUDE report 21411724 ↗
• InjurySep 27, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON (B)(6) 2024 THAT PATIENT STARTED EXPERIENCING ITCHING AND SCARING ON THE THEIR SKIN. THE PATIENT WENT TO URGENT CARE AND WHILE AT URGENT CARE THEY REMOVED THE C6 MCOT SENSOR AND UNIVERSAL PATCH. UPON REMOVING THE DEVICE IT WAS NOTED THAT A PIECE OF METAL POKING THE PATIENT AND IT THOUGHT IT WAS FROM THE UNIVERSAL PATCH. THE PATIENT WAS PRESCRIBED MUPIROCIN OINTMENT. THE PATIENT DID PERFORM SKIN PREP PRIOR TO PLACING THE DEVICE, HOWEVER IT WAS UNKNOWN IF THE PATIENT FOLLOWED THE PROPER SKIN PREP. THE PATIENT DOES HAVE A HISTORY OF SKIN SENSITIVITY TO ADHESIVES AND DOES NOT HAVE ANY SENSITIVITY/ALLERGIES TO METAL.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 20326381 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2024 THE PATIENT WAS BURNED BY THE C6 SENSOR WHILE THEY WERE SLEEPING. THE PATIENT REPORTED THAT THE SENSOR ELECTROCUTED AND "SEVERELY" BURNED THEM. THE PATIENT REPORTED THAT THERE WAS A BURN ON THEIR CHEST IN THE SHAPE OF THE SENSOR. THE PATIENT DETAILED THAT THE BURN WAS PAINFUL, VERY RED AND OPEN SORE AND RAW. DUE TO THE BURN THE PATIENT WENT TO THE URGENT CARE. IT IS UNCLEAR IF THEY BURN WAS TREATED WITH ANY MEDICATION. THIS REPORT IS RELATED TO 133409-2024-00052.

  Patient problems: Skin Inflammation/ Irritation; Superficial (First Degree) Burn

  MAUDE report 20055073 ↗
• InjuryJun 11, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT ON 29 APRIL 2024 THE PATIENT NOTICED BLISTERS, ITCHY, RAW SKIN THAT HURTS. THE PATIENT DID NOT USE ANY OVER THE COUNTER (OTC) TREATMENTS. THE PATIENT DID REPORT THAT THEY HAD PRE-EXISTING SKIN SENSITIVITIES. THE PATIENT WAS TAKING A BREAK IN SERVICE AND WAS GOING TO SWITCH TO LEADWIRE ADAPTER (LWA). ON (B)(6) 2024 THE PATIENT FOLLOWED UP AND REPORTED THAT THEY CLEANED THEIR SKIN USING SOAPY WATER, ALCOHOL PADS AND THEN CLEANED AGAIN WITH WARM SOAPY WATER AND DRIED. THE PATIENT WAS ALSO GIVEN A PRESCRIPTION FOR TRIAMCINOLONE.

  Patient problems: Blister; Itching Sensation; Skin Inflammation/ Irritation

  MAUDE report 19510219 ↗
• InjuryMay 29, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 02 MAY 2024 A 1 YEAR AND 2 MONTH YEAR OLD PATIENT EXPERIENCED A SKIN BRUN UNDER WHERE TH C6 SENSOR AND UNIVERSAL 2 CHANNEL ELECTRODES WAS SITTING. THE PATIENT'S MOTHER REPORTED THAT THE PATIENT IS CURRENTLY ON 10MG OF NADOLOL. THE PATIENT'S MOTHER DECLINED A REPLACEMENT HOWEVER THE PATIENT'S MOTHER SAID THEY WOULD SWITCH THE FLEX ADAPTER. THE PATIENT'S DOCTOR STATED THE BURN WAS AN ELECTRICAL BURN. THE PATIENT'S SKIN WAS CLEANED WITH WARM WATER, MILD SOAP EACH TIME THE ELECTRDOE WAS CHANGED.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 19416041 ↗
• InjuryMay 29, 2024Biocompatibility; Adverse Event Without Identified Device or Use Problem; Biocompatibility; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON 26 APRIL 2024 WHEN THE PATIENT WAS REMOVING THE UNIVERSAL PATCH TO SWAP OUT AND THEIR SKIN CAME OFF. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS GIVEN CORTISONE CREAM. THE PATIENT DID NOT REPORT ANY PRE EXISITING SKIN SENSITIBITY AND PREPPED THEIR SKIN AT THE DOCTOR'S OFFICE BY CLEANING AND DRYING.

  Patient problems: Peeling; Skin Tears

  MAUDE report 19414978 ↗
• InjuryJan 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS BURNED ON AREA BENEATH PATCH ON THE LEFT SIDE. THE PATIENT REPORTED THE SKIN WAS RED AND BURN CREATED A SHOCK AT THE BACK OF THE PATIENT'S HEAD DOWN THE LEFT SIDE. THE PATIENT ALSO REPORTED THAT THEY EXPERIENCED NUMBNESS DOWN THEIR LEFT SIDE. ADDITIONAL INFORMATION WAS REQUESTED BUT COULD NOT BE OBTAINED.

  Patient problems: Numbness; Shock; Skin Inflammation/ Irritation

  MAUDE report 18587331 ↗
• InjuryJan 26, 2024Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A RASH WHILE USING THE UNIVERSAL PATCH. THE PATIENT THOUGHT THAT IT MIGHT BE STRESS RASH AND DECIDED TO A BREAK IN SERVICE. ON 11 JANUARY 2024 THE PATIENT FOLLOWED-UP AND STATED THAT THEY DID SEEK MEDICAL ATTENTION FOR THE RASH AND WAS PRESCRIBED TRIAMCINOLONE ACETONIDE. THE PATIENT REPORTED THAT THEY PERFORMED A SKIN PREP OF USING WARM WATER AND SOAP. THE PATIENT ALSO HAS A HISTORY OF SENSITIVITY/ALLERGY OF MASS CELL ACTIVATION SYNDROME.

  Patient problems: Rash

  MAUDE report 18586570 ↗
• InjuryNov 16, 2023Biocompatibility; Biocompatibility

  PATIENT REPORTED THEY WERE EXPERIENCING SKIN BLISTERS THAT WERE THE SIZE OF THE UNIVERSAL PATCH. THE SKIN APPEARED WITH RED RAISED SKIN WITH A TEAR NEAR WERE THE TOP OF THE PATCH WOULD BE ON THE SKIN AND NEAR THE BOTTOM IT WAS VERY RED AND COMPLETELY BLISTERED. THE PATIENT WENT TO EMERGENCY ROOM (ER) AND WAS DIAGNOSED WITH ALLERGIC CONTACT DERMATITIS DUE TO THE ADHESIVE ON PATCH. THE PATIENT WAS PRESCRIBED HYDROCORTISONE. LEAD WIRE ADAPTER (LWA) AND FLEX WAS OFFERED AND THE PATIENT TOOK A BREAK IN SERVICE UNTIL SKIN COMPLETELY HEALED. THE PATIENT HAS A HISTORY OF ALLERGIES.

  Patient problems: Blister; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 18151217 ↗
• InjuryNov 7, 2023Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING SKIN IRRITATION UNDER THE PATCH. OTHER ELECTRODE OPTIONS WERE OFFERED TO THE PATIENT HOWEVER, THE PATIENT WANTED TO KEEP USING THE UNIVERSAL PATCH. THE PATIENT WAS PRESCRIBED A STEROID OINTMENT FOR THE SKIN IRRITATION AND CONTINUED WITH SERVICE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 18083415 ↗
• InjurySep 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED THAT THEY WENT TO URGENT CARE FOR FIRST DEGREE BURNS UNDER THE PATCH. THE PATIENT WAS PRESCRIBED OINTMENT AND SWITCHED TO FLEX ADAPTOR AND CONTINUED WITH SERVICE. AFTER SWITHCING TO FLEX THE PATIENT RETURNED TO URGENT CARE AND RECEIVED MORE OINTMENT DUE TO FIRST DEGREE BURNS. THE PATIENT RETURNED THE KIT AND DID NOT FINISH SERVICE. THE PATIENT DOES HAVE A HISTORY OF SKIN SENSITIVITY.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 17718911 ↗
• InjuryAug 18, 2023Biocompatibility; Biocompatibility

  THE PATIENT REPORTED THAT AFTER WEARING THE SENSOR FOR 5 DAYS THE PATIENT REMROVED THE PATCH AND NOTED DAMAGED SKIN WITH RED SMALL DOTS. A NEW PATCH WAS PLACED AND AFTER 9 DAYS THE PATIENT REPORTED SHE COULD NOT MOVED THE PATCH. AFTER STRUGGLING THE PATCH WAS REMOVED AND BLOOD BLISTERS WERE NOTED. SECTIONS OF THE ADHESIVE WERE NOTED STILL ON THE PATIENT'S SKIN. THE PATIENT CALLED HER DOCTOR AND WAS PRESCRIBED TO USE AN ANTIBOTIC CREAM.

  Patient problems: Blister; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 17573952 ↗
• InjuryAug 18, 2023Biocompatibility; Biocompatibility

  THE PATIENT REPORTED REDNESS OVER THE PAST COUPLE WEEKS WITH A "BURNING FIRE" FEELING AFTER CHANGING THE PATCH. THE PATIENT DROVE TO THE HOSPITAL AND WENT TO THE EMERGENCY ROOM (ER). THE ER DOCTOR SAID THE BURN ON THE PATIENT'S SKIN WAS NOT A BURN BUT A "DERMATOLOGY REACTION" DUE TO THE PATCH. THE PATCH WAS PEELING THE PATIENT'S SKIN OFF LAYER BY LAYER. THE ER DOCTOR PRESCRIBED A STEROID OINTMENT AND ANTIBIOTICS AND WAS ADVISED TO REMOVE THE DEVICE AND RETURN IT. THE PATIENT DOES NOT HAVE A HISTORY OF PRE-EXISTING SKIN SENSITIVITIES.

  Patient problems: Reaction to Medicinal Component of Device

  MAUDE report 17573038 ↗
• InjuryJul 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REPORTED SKIN IRRITATION, BLISTERS AND DISCHARGE OF FLUIDS. PATIENT FOLLOWED SKIN PREP REGIMEN. PATIENT STATED THEY RECEIVED PRESCRIPTION PILLS (BENADRYL CHEWABLE) AND ALSO USED NEOSPORIN. PATIENT WAS USING C6 PATCH AND CHOSE TO SWITCH TO LEAD WIRE ADAPTOR (LWA)/CLOTH ELECTRODES. PATIENT DECIDED TO TAKE BREAK IN SERVICE (BIS) TILL REPLACEMENT ELECTRODES ARE RECEIVED.

  Patient problems: Blister

  MAUDE report 17430443 ↗
• InjuryApr 24, 2023Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  THE PATIENT REPORTED A HUGE BLEEDING RASH AFTER WEARING THE FLEX PATCH FOR 48HOURS. THE PATIENT WAS ALSO IRRITATED BY THE UNIVERSAL PATCH. THE PATIENT REPORTED WAITING FOR 6 DAYS TO USE ANOTHER PATCH DUE TO INFECTED SKIN. PATIENT USED ALTERNATIVE SUPPLIES TO CONTINUE SERVICE. PATIENT WAS PRESCRIBED A "POWDER" (NYSTATIN 100,000 UNIT/GM POWDER) AFTER SEEING THE DOCTOR FOR THE IRRITATION OF THE SKIN. PATIENT INDICATES SHE HAS SENSITIVE SKIN. SKIN PREP REGIMEN WAS FOLLOWED.

  Patient problems: Blister; Skin Inflammation/ Irritation

  MAUDE report 16794741 ↗
• InjuryFeb 17, 2023Patient-Device Incompatibility; Biocompatibility; Patient-Device Incompatibility; Biocompatibility

  PATIENT REPORTED OPEN, WET, AND BLEEDING BLISTERS. SKIN WAS PREPPED BY WASHING WITH WARM WATER, SOAP AND DRIED. PATIENT WENT TO ER, CORTISONE CREAM APPLIED. PATIENT WORE MONITOR FOR 5 DAYS AND HAD TO REMOVE DUE TO THE SKIN IRRITATION. PATIENT RETURNED THE MONITOR, BUT DID NOT RETURN THE PATCH WHICH IS WHAT CAUSED THE SKIN ISSUE. PATIENT DISCONTINUED SERVICE.

  Patient problems: Blister; Skin Inflammation/ Irritation; Skin Tears

  MAUDE report 16401162 ↗
• InjuryJan 10, 2023Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem; Patient-Device Incompatibility; Biocompatibility; Patient Device Interaction Problem

  THE PATIENT EXPERIENCED AN ANAPHYLACTIC REACTION FROM WEARING THE PATCH AND RECEIVED MEDICAL TREATMENT IN THE EMERGENCY ROOM. PATIENT SERVICES SUPPORT (PSS) PERFORMED MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. HOWEVER, NO FURTHER DETAILS HAVE BEEN RECEIVED REGARDING THE INCIDENT.

  Patient problems: Anaphylactic Shock; Erythema; Hypersensitivity/Allergic reaction; Local Reaction; Skin Inflammation/ Irritation

  MAUDE report 16134077 ↗
• InjuryNov 18, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  BIOTEL HEART PATIENT REPORTED HIVES STARTED ON (B)(6), THEN BECAME BLISTERS TO OPEN BURNS THAT ARE NOW DISCHARGING FLUIDS. PATIENT'S PHYSICIAN TOLD HER TO CALL PHILIPS TO NOTIFY. PATIENT WAS PRESCRIBED ANTI-ITCH MEDICATION TRIAMCINOLONE. PATIENT STATED SHE HAS A HISTORY OF SKIN SENSITIVITY.

  Patient problems: Blister; Erythema; Hypersensitivity/Allergic reaction; Local Reaction; Skin Inflammation/ Irritation

  MAUDE report 15825001 ↗