MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO XT HEART MONITOR; RECORDER, MAGNETIC TAPE, MEDICAL

Model Number THERE'S ONLY ONE MODEL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Blister (4537); Skin Disorders (4543); Skin Inflammation/ Irritation (4545)

Event Date 05/17/2021

Event Type  Injury  

Event Description

My doctor asked me to use a zio xt heart monitor.It was applied on (b)(6) 2021.Prior to placing it on, the technician scrubbed my skin with an abrasive pad provided by the monitor company.It was way too intense, and my skin was inflamed and beet red when they adhered the heart monitor.Several days later, i could see contact dermatitis under the adhesive and around the adhesive where the technician had scrubbed my skin.I also had two open blisters under the adhesive strip.I called the monitor (b)(4) number and they instructed me on how to remove.I only wore the monitor for 3 1/2 days (the doctor wanted 7 days) and i went to my dermatologist the following day.It's an acute dermatitis and i'm now on a topical steroid, triamcinolone.Fda safety report id # (b)(4).

• Brand Name: ZIO XT HEART MONITOR
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 11855345
• MDR Text Key: 252141388
• Report Number: MW5101472
• Device Sequence Number: 1
• Product Code: DSH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/18/2021

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 Model Number: THERE'S ONLY ONE MODEL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/19/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 61