Carnation Ambulatory Monitor B1000R7000Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 20851398007010), received between Aug 8, 2024 and Dec 4, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PATIENT EXPERIENCED IRRITATION AND BURNING WHILE WEARING THE DEVICE. WENT TO URGENT CARE AND WAS PRESCRIBED MEDICATION" ADDITIONAL INFORMATION: THE PATIENT INDICATED THAT THE IRRITATION SPREAD BETWEEN THE COLLARBONE DOWN TO THE STOMACH. THE PATIENT INDICATED THAT THEY VISITED A MEDICAL PROFESSIONAL THAT PRESCRIBED ORAL PREDNISONE DAILY FOR A 5-DAY PERIOD. BARDY DIAGNOSTICS WAS MADE AWARE THAT THE PATIENT'S IRRITATION WAS "NO LONGER RED" FOLLOWING THEIR TREATMENT. THE DEVICE WAS REQUESTED TO BE RETURNED ON 13 NOV 2024. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN OBTAINED TO PERFORM AN INVESTIGATION OR FAILURE ANALYSIS.

  Patient problems: Contact Dermatitis; Skin Inflammation/ Irritation

  MAUDE report 20846909 ↗
• InjurySep 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PATIENT REPORTED NEEDING TO TAKE THE CAM OFF D/T SKIN IRRITATION AND BLISTERS". ADDITIONAL INFORMATION: THE PATIENT STATED THEY WERE GIVEN PREDNISONE AND ORAL ANTIBIOTIC BY THE SURGICAL CENTER BUT WAS UNABLE TO PROVIDE THE NAME OF THE ANTIBIOTIC MEDICATION. THE PATIENT ALSO STATED THEY WERE GIVEN LIDOCAINE AT A SURGICAL CENTER. THE PATIENT MENTIONED BLISTERING, OOZING, AND EXTREME ITCHING. THEY STATED THAT THEY WENT TO A SURGICAL CENTER FOR CARE AND WERE PLACED ON PREDNISONE AND AN ANTIBIOTIC. THE EFFECT WAS ISOLATED TO THE AREA OF THE PATCH WHICH WAS THE UPPER LEFT BREAST OF THE PATIENT. THIS IS NOT THE DIRECTED LOCATION OF APPLICATION PER THE CAM INSTRUCTIONS FOR USE. THE PATIENT MENTIONED THAT IT TOOK 2 WEEKS FOR THE IRRITATION TO SUBSIDE. THE DEVICE WAS REQUESTED TO BE RETURNED ON 20 SEP 2024. AT THE TIME OF THIS REPORT, THE DEVICE HAS NOT BEEN OBTAINED TO PERFORM AN INVESTIGATION OR FAILURE ANALYSIS.

  Patient problems: Contact Dermatitis; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 20314157 ↗
• InjuryAug 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS WRITTEN FROM THE COMPLAINT (B)(4) DESCRIPTION: "PER PATIENTS DIARY: "TOOK OFF - SEVERE IRRITATION" PER PATIENTS EMAIL: "I HAD A SEVERE ALLERGIC REACTION THAT LEFT WHAT LOOKED LIKE A CHEMICAL BURN THAT BLISTERED THE WHOLE LENGTH OF WHERE THE MONITOR WAS ADHERRED ON MY CHEST AND HAD TO BE TREATED BY MY PRIMARY CARE FOR A BURN. IT WAS VERY PAINFUL FOR TWO WEEKS AND I STILL CAN SEE THE MARK." ADDITIONAL INFORMATION: THE PRIMARY CARE DOCTOR TREATED THE PATIENT WITH TOPICAL STEROID CREAM AND "BURN CREAM" AND SUGGESTED THE PATIENT NOT USE THIS TYPE OF ADHESIVE ANYMORE. THE MEDICATION USED WAS: PREDNISONE 10 MG ORAL TABLETS & SILVADENE CREAM (TOPICAL TREATMENT). SKIN PREP WAS LIMITED TO ALCOHOL WIPES PROVIDED BY THE PRODUCT KIT. IT TOOK APPROXIMATELY TWO WEEKS FOR THE REACTION TO HEAL OVER, HOWEVER THERE WAS STILL A VISIBLE MARK AS OF (B)(6) 2024.

  Patient problems: Contact Dermatitis; Skin Discoloration; Skin Inflammation/ Irritation

  MAUDE report 19939218 ↗