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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. ZIO XT COMPUTER, DIAGNOSTIC, PROGRAMMABLE

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IRHYTHM TECHNOLOGIES, INC. ZIO XT COMPUTER, DIAGNOSTIC, PROGRAMMABLE Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Itching Sensation (1943); Rash (2033)
Event Date 03/16/2021
Event Type  Injury  
Event Description
Subject no. (b)(6) was screened and randomized on (b)(6) 2021 for protocol (b)(4). Subject was randomized to zio xt monitor arm and the device was applied at the visit per protocol. Subject had no known allergies to any adhesive prior to the enrollment. After few hours, subject developed a rash and itchiness. Subject contacted irhythm customer care and they instructed him to remove and return the device. Fda safety report id # (b)(4).
 
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Brand NameZIO XT
Type of DeviceCOMPUTER, DIAGNOSTIC, PROGRAMMABLE
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC.
MDR Report Key11602734
MDR Text Key243636405
Report NumberMW5100481
Device Sequence Number1
Product Code DQK
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date05/30/2021
Device Model NumberN/A
Device Catalogue NumberN/A
Device Lot NumberN/A
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/22/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 03/31/2021 Patient Sequence Number: 1
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