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

Lot Number 04/13/2021

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Hypersensitivity/Allergic reaction (1907); Rash (2033)

Event Date 01/26/2021

Event Type  Injury  

Event Description

Patient developed a local skin irritation/rash where the device was applied.She describes it as red and burning.Prior to device application, patient signed an informed consent form and was educated that this is a known side effect of the device.Patient was instructed to remove the device at home and the device will be returned to the manufacturer.Fda safety report id #: (b)(4).

• Brand Name: ZIO XT MONITOR
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES INC
• MDR Report Key: 11250851
• MDR Text Key: 229646687
• Report Number: MW5099082
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 04/13/2021
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 74 YR