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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Itching Sensation (1943); Rash (2033); Blister (4537)

Event Date 08/20/2022

Event Type  Injury  

Event Description

Product caused me to itch, break out in a red rash, and develop blisters.I have no history of skin sensitivity.Fda safety report id# (b)(4).

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 15293622
• MDR Text Key: 298704927
• Report Number: MW5111712
• 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: 08/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: GLUCOSAMINE
• Patient Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White