CAM SYSTEM
Received Jul 2, 2026
Report 3014226707-2026-00005 · MDR key 25696701
Device
Generic name
Heart Monitoring Device
Manufacturer
Bardy Diagnostics, Inc.Model number
B7000Lot number
195399
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
78 YR · Unknown
- Anaphylactic Shock
- Hypersensitivity/Allergic reaction
Narrative
Additional Manufacturer Narrative
THE DEVICE HISTORY RECORD (DHR) FOR UNIT (B)(6) CORRESPONDING TO COMPLAINT REFERENCE NUMBER: (B)(4), HAS BEEN REVIEWED FOR COMPLIANCE WITH ESTABLISHED DEVICE MASTER RECORD (DMR), INCLUDING CERTIFICATES OF CONFORMANCE FOR PATIENT CONTACT MATERIALS. EXAMINATION OF DEVICE RECORDS DETERMINED NO DISCREPANCIES OR INSTANCES OF NON-CONFORMITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CAM PRODUCT INSTRUCTIONS FOR USE (IFU) LISTS SKIN IRRITATION, ALLERGIC SKIN REACTIONS, AND ALLERGIC SYMPTOMS AS POTENTIAL RISKS ASSOCIATED WITH DEVICE USE. THE IFU INSTRUCTS PATIENTS TO REMOVE THE CAM IMMEDIATELY AND CONTACT THEIR PHYSICIAN IF IRRITATION SUCH AS REDNESS, SEVERE ITCHING, OR ALLERGIC SYMPTOMS DEVELOP.
Description of Event or 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.