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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT PATCH

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IRHYTHM TECHNOLOGIES, INC ZIO AT PATCH Back to Search Results
Model Number A100A100X
Device Problem Use of Device Problem (1670)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 09/23/2020
Event Type  Injury  
Manufacturer Narrative

Skin irritation is a known inherent risk of the device. Clinical ref. Manual (alb0031- at) warnings state the following: do not use the zio xt patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies. Patient may experience skin irritation. If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient's chest.

 
Event Description

The patient presented to their healthcare provider with a probable contact dermatitis where treatment was prescribed.

 
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Brand NameZIO AT PATCH
Type of DeviceAT PATCH
Manufacturer (Section D)
IRHYTHM TECHNOLOGIES, INC
699 8th st
suite 600
san francisco CA 94103
Manufacturer (Section G)
IRHYTHM TECH, INC
11085 knott avenue
suite b
cypress CA 90630
Manufacturer Contact
mazi kiani
699 8th st
suite 600
san francisco, CA 94103
9494132147
MDR Report Key10698231
MDR Text Key211937452
Report Number3007208829-2020-00072
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK163512
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial
Report Date 09/23/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/19/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date02/11/2021
Device MODEL NumberA100A100X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/24/2020
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/19/2020 Patient Sequence Number: 1
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