MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO AT; DETECTOR AND ALARM, ARRHYTHMIA

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Inflammation/ Irritation (4545); Unspecified Tissue Injury (4559)

Event Date 04/03/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported skin irritation with signs of secondary infection caused by zio at.The patient, who is also a doctor, prescribed the treatment for herself.The patient was contacted for follow up but could not be reached due to invalid contact information.This case is being reported out of an abundance of caution due to the inability to confirm the physicians indication for prescribing the treatment.Skin irritation is a known inherent risk of the device.Device manual warnings section read as follows: 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.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 reported skin irritation with signs of secondary infection caused by zio at.The patient, who is also a doctor, prescribed a cream to treat the area.

• Brand Name: ZIO AT
• Type of Device: DETECTOR AND ALARM, ARRHYTHMIA
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 16856176
• MDR Text Key: 314415589
• Report Number: 3007208829-2023-00025
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163512
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/17/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Sex: Female