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

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Cellulitis (1768); Contact Dermatitis (4546)

Event Date 07/26/2023

Event Type  Injury  

Manufacturer Narrative

The patient reported skin irritation with signs of secondary infection alleged to be caused by zio at.The patient was diagnosed with contact dermatitis and cellulitis and was prescribed treatment by their healthcare provider.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.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.This event is being reported per 21 cfr 803 as a serious injury.This report does not constitute an admission by irhythm that the product described in this report has any defects, or has malfunctioned.These terms are included in form fda 3500a and are fixed terms for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.

Event Description

The patient reported skin irritation with signs of secondary infection alleged to be caused by zio at.The patient was diagnosed with contact dermatitis and cellulitis and was prescribed treatment by their healthcare provider.

• 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: 17646520
• MDR Text Key: 322223817
• Report Number: 3007208829-2023-00043
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 10/31/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2023
• Date Manufacturer Received: 07/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2023
• 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