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

Model Number ZIO XT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Itching Sensation (1943); Burning Sensation (2146); Superficial (First Degree) Burn (2685); Skin Inflammation/ Irritation (4545)

Event Date 01/28/2022

Event Type  Injury  

Event Description

A zio patch was placed on my left chest for 2 weeks.Upon placement i noticed my chest itched and i felt a burning sensation: i was told i would get used to it.2 weeks later on (b)(6) 2022, upon removal of the patch, i noticed my skin was burnt under the location of the medical device (not under the adhesive part but under the part that the button is pressed when you have chest pain).I did record in the book several times throughout the 2 weeks (so i did push the button).I don't think pushing the button caused greater irritation.It was a constant and persistent irritation.I called the company today and notified them of this event and that i would also notify the fda because no one told me that i would have a burn to my skin upon removal.I think this is a possible side effect , we should be notified before placement.The company rep today explained that some patients do experience irritation.This is a burn, not simple irritation (not just a rash).I am allergic to latex.It is unclear to me if this device has latex, but if it did, i would have expected to see the burn over all areas (including the adhesive portion).This was not the case.The areas covered by adhesive is perfectly fine and clear.Fda safety report id# (b)(4).

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC. ORANGE COUNTY
• MDR Report Key: 13543680
• MDR Text Key: 285756231
• Report Number: MW5107499
• 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: Patient
• Type of Report: Initial
• Report Date: 02/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2022
• Device Model Number: ZIO XT
• Device Lot Number: N696366606
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: HUMALOG INSULIN; TANDEM PUMP; VITAMINS
• Patient Outcome(s): Other
• Patient Age: 50 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic
• Patient Race: White