• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

IRHYTHM TECHNOLOGIES, INC ZIO AT PATCH ZIO PATCH Back to Search Results
Model Number A100A100X
Device Problem Use of Device Problem (1670)
Patient Problem Skin Inflammation/ Irritation (4545)
Event Date 04/09/2021
Event Type  Injury  
Manufacturer Narrative

Skin irritation is a known inherent risk of the device. Clinical ref. Manual (alb0031) warnings state the following: do not use the zio at 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 at patch from the patient's chest.

 
Event Description

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

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameZIO AT PATCH
Type of DeviceZIO 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 Key11753213
MDR Text Key248204313
Report Number3007208829-2021-00040
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 CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 04/09/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/30/2021
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/19/2021
Device MODEL NumberA100A100X
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/12/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/09/2021
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/23/2021
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: 04/30/2021 Patient Sequence Number: 1
-
-