MAUDE Adverse Event Report: TZ MEDICAL, INC. HOLTER MONITOR; DETECTOR AND ALARM, ARRHYTHMIA

Model Number CLARUS 3

Device Problems Circuit Failure (1089); Melted (1385); Temperature Problem (3022)

Patient Problems Bruise/Contusion (1754); Superficial (First Degree) Burn (2685)

Event Date 05/16/2023

Event Type  Injury  

Event Description

13yr old child was given tz holter monitor, placed at (b)(6) hospital on 5/15.Was placed by staff and left on for 24 hrs as required.Child wore as directed.Did not shower even though it was supposed to be ok.Did not play sports.Mostly laid around the house with device on.It was not misused, tampered with, etc.Came to us stating that her chest hurt and was hot.Stated it was very hot at some point in the night.Once we removed device and tx medical company supplied sticker, we found she had small 1st deg burn to chest with some slight bruising.The device appears to have short circuited.Part of plastic holder for device was melted.Again, didn't get wet.No lotions or products applied.She had low activity while using.It was not tampered with.Tz medical inc model clarus 30.

Event Description

Additional information received for report mw5117741 on 05/25/2023 to update procode to dsi.

• Brand Name: HOLTER MONITOR
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): TZ MEDICAL, INC.
• MDR Report Key: 16974662
• MDR Text Key: 315788751
• Report Number: MW5117741
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Model Number: CLARUS 3
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/25/2023
• Patient Sequence Number: 1
• Treatment: ATENOLOL, VYVANSE. MEDICAL HOLTER FOR 24 HOUR.
• Patient Outcome(s): Other
• Patient Age: 12 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White