MAUDE Adverse Event Report: BARDY DIAGNOSTICS INC. BARDY CAM PATCH MONITOR; RECORDER, MAGNETIC TAPE, MEDICAL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blister (4537); Skin Inflammation/ Irritation (4545)

Event Date 10/25/2021

Event Type  Injury  

Event Description

Patient had a bardy ambulatory ecg monitor applied.The monitor was scheduled to be worn for 14 days, but patient removed the monitor after about 6 days due to skin irritation and blistering.Fda safety report id# (b)(4).

• Brand Name: BARDY CAM PATCH MONITOR
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): BARDY DIAGNOSTICS INC.; seattle WA 98104
• MDR Report Key: 15121358
• MDR Text Key: 296851778
• Report Number: MW5111151
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White