Carnation Ambulatory Monitor B1000R1400Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 40851398007014), received between Jan 12, 2024 and Sep 4, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Contact Dermatitis; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 50620118 ↗
• InjurySep 4, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Contact Dermatitis; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 50620115 ↗
• InjuryAug 27, 2026Adverse Event Without Identified Device or Use Problem

  Original Complaint (from (b)(4)):"The pt states she had a severe reaction to the patch, she removed and returned it to the prescribing hospital. The hospital prescribed her cortisone cream and pill. The pt states the rash stayed for months".Additional Information:Available information indicates the patient experienced irritation at the device application site. The patient sought medical treatment and was prescribed a topical corticosteroid cream and an oral steroid medication. The patient reported that the irritation was localized to the exact area where the monitor had been worn and did not spread beyond the application site.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 50487120 ↗
• InjuryAug 20, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 50358906 ↗
• InjuryJul 21, 2026Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4) (2311)): "CAM ADHESIVE CAUSED SKIN IRRITATION IN CENTER OF CHEST WHICH SPREAD TO NECK AREA. SKIN BECAME ITCHY, RED AND BURNING. IRRITATION LEFT SCAR ON CHEST AREA. PATIENT STATED HAD TO GO TO URGENT CARE FOR TREATMENT AND WAS PRESCRIBE TRIAMCINOLONE." ADDITIONAL INFORMATION: MULTIPLE ATTEMPTS WERE MADE TO CONFIRM IF THE PRESCRIBED TRIAMCINOLONE WAS TOPICAL OR ORAL DETAILS WITHOUT SUCCESS. IT IS UNKNOWN IF THE PATIENT USED A TOPICAL OR ORAL PRESCRIPTION.

  Patient problems: Contact Dermatitis; Hypersensitivity/Allergic reaction; Skin Inflammation/ Irritation

  MAUDE report 25898918 ↗
• InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4): "THE PATIENT REPORTED IN EMAIL "A MONITOR WAS PLACED ON MY CHEST, THIS AFTERNOON. A COUPLE HOURS LATER, MY ESOPHAGUS IS CAUSING CHOCKING, RIGHT ALONG AND UNDER THE MONITOR". ADDITIONAL INFORMATION: MULTIPLE ATTEMPTS WERE MADE TO OBTAIN TREATMENT DETAILS WITHOUT SUCCESS. IT IS UNKNOWN IF THE PATIENT RECEIVED TREATMENT TO TREAT THE REACTION.

  Patient problems: Anaphylactic Shock; Hypersensitivity/Allergic reaction

  MAUDE report 25696701 ↗
• InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4): "THE PT STATES THE DEVICE CAUSED HIM TO TURN RED/ HE STATES HE IS ALLERGIC TO NICKEL." ADDITIONAL INFORMATION: THE PATIENT REPORTED A KNOWN ALLERGY TO NICKEL AND STATED THAT USE OF THE DEVICE RESULTED IN SKIN REACTIONS INCLUDING REDNESS, BURNING, AND ITCHING. THE PATIENT FURTHER REPORTED THAT THE REACTION SPREAD ACROSS THE CHEST AND ABDOMEN. THE PATIENT SOUGHT MEDICAL ATTENTION IN THE EMERGENCY ROOM, WHERE HE REPORTED RECEIVING AN UNSPECIFIED INJECTION, AS WELL AS TREATMENT WITH HYDROXYZINE AND NAPROXEN. ADDITIONAL ATTEMPTS WERE MADE TO IDENTIFY THE INJECTED MEDICATION; HOWEVER, THESE EFFORTS WERE UNSUCCESSFUL. PRIOR COMPLAINT (B)(4) INVOLVED THE SAME CAM ID AND INSTITUTION. TWO ATTEMPTS WERE MADE AT THAT TIME TO OBTAIN ADDITIONAL INFORMATION ABOUT THE REACTION AND TREATMENT WITH NO RESPONSE. NO ADDITIONAL INFORMATION WAS OBTAINED AT THAT TIME.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 25492484 ↗
• InjuryMay 15, 2026Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4): "PARENT OF PT CALLED TO REPORT THAT THEIR CHILD HAD A SEVERE REACTION TO THE ADHESIVE OF THE MONITOR. THEY DESCRIBED IT AS AN ITCHY RED RASH THAT HAD FORMED BLISTERS THAT SPREAD AND REQUIRED MEDICAL INTERVENTION" ON (B)(6) 2026, A COMPLAINT WAS RECEIVED REPORTING THAT A PEDIATRIC PATIENT EXPERIENCED A DERMATOLOGIC REACTION AT THE SITE OF MONITOR ADHESIVE APPLICATION, DESCRIBED AS AN ITCHY RED RASH WITH BLISTERING THAT SPREAD TO APPROXIMATELY THREE TIMES THE SIZE OF THE DEVICE PLACEMENT AREA. MEDICAL EVALUATION WAS SOUGHT, AND IT WAS INITIALLY REPORTED THAT PRESCRIPTION MEDICATION WAS PROVIDED TO TREAT A POTENTIAL INFECTION; HOWEVER, SPECIFIC MEDICATION DETAILS COULD NOT BE OBTAINED PRIOR TO MDR SUBMISSION ON 20-MAR-2026. ADDITIONAL INFORMATION RECEIVED ON 7-MAY-2026 CONFIRMED THE PATIENT WAS TREATED WITH OVER-THE-COUNTER MEDICATIONS, SPECIFICALLY TOPICAL HYDROCORTISONE AND CETIRIZINE (ZYRTEC), WITH NO PRESCRIPTION MEDICATIONS ADMINISTERED.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 25193530 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4): "PATIENT WROTE IN DIARY, "REMOVED/ADHESIVE DISCOMFORT"" ADDITIONAL INFORMATION: THE PATIENT REPORTED DEVELOPING AN ITCHY, RED RASH UNDER THE RING ADHESIVE PLACED OVER THE DEVICE. TWO DAYS AFTER REMOVING THE MONITOR, THE PATIENT EXPERIENCED A SHINGLES OUTBREAK CONFIRMED BY A PHYSICIAN. THE SHINGLES APPEARED ON THE PATIENT'S BACK AND SIDE AND SPREAD TO THE LEFT BREAST. THE PATIENT STATED THEY HAVE AN ADHESIVE ALLERGY BUT HAD NEVER EXPERIENCED SHINGLES BEFORE. THEY WERE UNSURE WHETHER THE SHINGLES WERE TRIGGERED BY THE ADHESIVE REACTION OR OCCURRED COINCIDENTALLY. FURTHER DETAILS: THE RASH OCCURRED WHILE THE PATIENT WAS WEARING THE DEVICE AND WAS LOCALIZED UNDER THE RING ADHESIVE. THE PATIENT SOUGHT TREATMENT AND WAS PRESCRIBED ORAL ANTIVIRAL MEDICATION (ZALTREX), WHICH THEY REPORTED WAS HELPING. THE PATIENT DESCRIBED THE SKIN REACTION AS ITCHY AND RED, WITH THE RASH SPREADING BEYOND THE ADHESIVE SITE AFTER MONITOR REMOVAL.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 23845749 ↗
• InjuryDec 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ORIGINAL COMPLAINT (FROM (B)(4)): " PATIENT WROTE IN DIARY "DEVICE REMOVED DUE TO RASH"". ADDITIONAL INFORMATION: THE PATIENT REPORTED THAT THE RASH WAS DUE TO A DRUG REACTION. THEY BEGAN A NEW MEDICATION THE DAY AFTER STARTING THE MONITOR. THE PATIENT DESCRIBED ITCHY SPOTS INITIALLY APPEARING ON THE LEGS, THEN SPREADING UPWARD TO THE TORSO, REACHING THE AREA WHERE THE MONITOR WAS PLACED, AND EVENTUALLY EXTENDING TO THE COLLARBONE. THE PATIENT REMOVED THE MONITOR TO ALLOW TREATMENT OF THE REACTION. FURTHER DETAILS: THE REACTION OCCURRED WHILE THE PATIENT WAS WEARING THE DEVICE. THE PATIENT TREATED THE RASH WITH CALAMINE AND MENTHOL CREAMS AVAILABLE AT HOME AND RECEIVED A PRESCRIPTION FOR ORAL PREDNISONE. THE PATIENT STATED THAT THE NEW MEDICATION, BUPROPION, CAUSED THE REACTION AND EXPRESSED CERTAINTY THAT THE MONITOR WAS NOT RESPONSIBLE. THE PATIENT INDICATED THAT THEIR PHYSICIAN AGREED WITH THIS ASSESSMENT.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 23845642 ↗
• InjuryDec 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT LEFT A NOTE IN THE BOX STATING WOKE UP WITH [GENERALIZED] ITCHY RASH." ADDITIONAL INFORMATION PROVIDED BY THE PATIENT: (25 NOV 2025) SHE DOES NOT BELIEVE IT WAS FROM MONITOR BECAUSE SHE NOTICED IT THE DAY, SHE WAS SCHEDULED TO REMOVE THE DEVICE AND IT WAS NOT LOCALIZED TOO THE MONITOR PLACEMENT. THE RASH SPREAD. SHE SAID IT WAS ON HER BACK, LEGS AND STOMACH. THE PATIENT WENT TO A PROMPT CARE AND WAS PRESCRIBED ORAL PREDNISONE. THE PATIENT STATED SHE ONLY TOOK IT FOR 2 DAYS BECAUSE IT WAS CAUSING PVCS (PREMATURE VENTRICULAR CONTRACTIONS). THE PATIENT ALSO USED VASELINE ON HER SKIN TO HELP WITH ITCHING. ADDITIONAL DETAILS: THE PATIENT STATED MULTIPLE TIMES SHE DID NOT BELIEVE THE MONITOR TO BE THE CAUSE OF THE RASH, BUT WAS UNCERTAIN WHAT DID CAUSE IT. THERE IS STILL A SLIGHT IMPRINT OF THE CAM ON THE PATIENT'S CHEST, BUT IT IS GOING AWAY. THE PATIENT DID NOT MENTION THAT AN ADHESIVE RING WAS USED, HOWEVER IT WAS NOTICED WHEN THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS THAT AN ADHESIVE RING WAS ATTACHED TO THE DEVICE.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 23835438 ↗
• InjuryAug 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE (B)(4) COMPLAINT DESCRIPTION: PATIENT WROTE ON DIARY "OFF AT 6:48PM 6-26 DUE TO HIVES". ADDITIONAL INFORMATION OBTAINED FROM THE PATIENT REGARDING THEIR SKIN IRRITATION ON (B)(6) 2025: PLEASE DESCRIBE THE SKIN REACTION IN DETAIL: THE PATIENT SAID THAT THE ADHESIVE FROM THE DEVICE CAUSED HER TO BREAK OUT IN ITCHY HIVES THAT SPREAD ALL OVER HER BODY. PATIENT DID REACH OUT TO HER DOCTOR AND THEY PRESCRIBED HER PREDNISONE AND BETAMETHASONE TABLETS WHICH HELPED HER SKIN AND THE HIVES SLOWLY WENT AWAY. IT HAS HAPPENED BEFORE. SHE ASKED FOR PAPER TAPE AT THE DOCTOR'S OFFICE AND THEY SAID NO. HER SKIN HAS CLEARED UP AND IS FINE NOW. ADDITIONAL INFORMATION: THE DEVICE WAS RECEIVED FOR INVESTIGATION ON 30 JUL 2025. FAILURE ANALYSIS WAS COMPLETED AND NO DEVICE NONCONFORMANCE OBSERVED.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 22745079 ↗
• InjuryApr 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "THE PATIENT LEFT A TYPED NOTE INSIDE THE BOX THAT STATES "ON THURSDAY (B)(6), I DID NOT HAVE ABNORMAL HEART SYMPTOMS BUT I DID NOTICEREDNESS AROUND THE DEVICE. BY FRIDAY, I STILL HAD NO HEART SYMPTOMS BUT THE REDNESS HAD BECOME MORE SEVERE. I WAS CONCERNED BECAUSE I HAD SUFFERED FROM ADHESIVE ALLERGIES IN THE PAST. IN ADDITION TO THE REDNESS AROUND THE DEVICE, BY SATURDAY THE AREA INCLUDED RASH TYPE BUMPS, ITCHING, BURNING, AND CLEAR LIQUID DRAINAGE. SINCE THE CONDITION WORSENED, I WAS SENT BY VA EMERGENCY TO COMMUNITY URGENT CARE. THE DESCRIBED MY CONDITION AS "CONTACT DERMATITIS". THEY REDRESSED THE AREA BUT BY THAT TIME THE DEVICE WAS TOO SATURATED TO STAY IN PLACE. NEW BANDAGES WERE APPLIED AND I WAS PRESCRIBED HYDROXYZ HCL 25 MG. I REMOVED THE NEW BANDAGE AND THE DEVICE FOR RETURN ON MONDAY (B)(6) WITHOUT EXPERIENCING ABNORMAL HEART OR CHEST SYMPTOMS SINCE THE ORIGINAL APPLICATION."" ADDITIONAL INFORMATION: THE DEVICE WAS RECIEVED FOR INVESTIGATION ON 09 APR 2025. FAILURE ANALYSIS CONCLUDED NO DEVICE NONCONFORMATIES.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 21923224 ↗
• InjuryJan 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PATIENT WROTE A DIARY ENTRY ON (B)(6) 2024 STATING, "REMOVED DEVICE DUE TO RASH"." ADDITIONAL INFORMATION: THE PATIENT STATED THAT THEY REMOVED THE DEVICE AFTER 12 DAYS FROM DEVELOPING THE RASH AND INDICATED THAT THE IRRITATION SPREAD BEYOND WHERE THE DEVICE WAS APPLIED. THE PATIENT SOUGHT TREATMENT AND WAS PRESCRIBED ORAL PREDNISONE AND BENADRYL. THE PATIENT INDICATED THAT THE IRRITATION HAS SINCE IMPROVED SINCE TAKING THE PRESCRIBED MEDICATION. THE DEVICE WAS REQUESTED TO BE RETURNED ON 06 JAN 2025 AND DELIVERED TO THE MANUFACTURER ON 09 JAN 2025. THERE HAS BEEN NO INDICATION OF A DEVICE NON-CONFORMANCE. IT WAS FOUND THAT AN UNKNOWN ADHESIVE FILM (NOT BARDYDX RECOMMENDED TEGADERM) WAS APPLIED OVER THE DEVICE.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 21260899 ↗
• InjuryJan 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "NOTE INCLUDED IN THE BOX SAYS, "RED, BURNING, ITCHY SKIN UNDER TEGADERM HOLDING THE HOLTER MONITOR". " ADDITIONAL INFORMATION: THE PATIENT'S MOTHER NOTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE MONITOR AND BROKE OUT IN BLISTERS. IT WAS NOTED THAT THE IRRITATION WAS LOCALIZED TO THE SURROUNDING AREA OF THE DEVICE AND THE TEGADERM ADHESIVE; IRRITATION DID NOT GO BEYOND THE TEGADERM. THE PATIENT DID SEEK TREATMENT FOR THE SKIN IRRITATION AND WAS LATER PRESCRIBED VISTARIL THAT WAS TAKEN ORALLY. THE PROVIDER INSTRUCTED THE USER TO REMOVE JUST THE TEGADERM AND CONTINUE THE WEAR STUDY. THE PATIENT THEN REMOVED THE DEVICE AFTER FOUR ADDITIONAL DAYS. ON (B)(6) 2024, THE PATIENT'S MOTHER COMMUNICATED THAT THE SKIN IRRITATION HAD IMPROVED. THE DEVICE WAS REQUESTED TO BE RETURNED ON 18 DEC 2024 AND DELIVERED TO THE MANUFACTURER ON 26 DEC 2024. THERE HAS BEEN NO INDICATION OF A DEVICE NON-CONFORMANCE.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 21064148 ↗
• InjuryNov 24, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN ECG REPORT WAS ASSOCIATED TO THE INCORRECT PATIENT AS A RESULT OF A REGISTRATION USER ERROR. THAT PATIENT WAS SUBSEQUENTLY PRESCRIBED ELIQUIS FOR AN ARRHYTHMIA THAT THEY DID NOT HAVE. THE HEALTHCARE PROVIDER INDICATED THE PATIENT DID NOT HAVE BLEEDING COMPLICATIONS FROM THE PRESCRIBED ELIQUIS. THERE IS NO EVIDENCE OF A DEVICE MALFUNCTION. PATIENT AGE IS UNKNOWN. DATE OF EVENT IS UNKNOWN, BUT DID OCCUR WITHIN 2024.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20768807 ↗
• InjuryJan 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE SUBMITTED COMPLAINT FILE: "PATIENT STARTED WEARING THE CAM ON 05-DEC-2023 AND CALLED (B)(6) ON 06-DEC-2023 AND COMPLAINED OF SKIN IRRITATION AND SHORTNESS OF BREATH. SHE HAD TO USE HER EPI PEN. SHE REMOVED THE CAM. THE PROVIDER DOES NOT WANT A NEW CAM PLACED." NOTE: FURTHER COMMUNICATION FOLLOW-UP DETERMINED THERE WAS NO SKIN IRRITATION. ALL OTHER INFORMATION FROM THE ORIGINAL COMPLAINT DESCRIPTION WAS VERIFIED.

  Patient problems: Anaphylactic Shock; Hypersensitivity/Allergic reaction

  MAUDE report 18503909 ↗