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

Device Problem Use of Device Problem (1670)

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 03/26/2022

Event Type  Injury  

Manufacturer Narrative

Investigation into the reported skin irritation does not suggest the issue is attributable to the device.While skin irritation is a known inherent risk of the device, communication with the patient suggests the most likely cause of the reported issue is user error.Per the patient, the reported skin irritation occurred following the skin preparation process, prior to device application.Clinical ref.Manual (alb0031- at) 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.Additionally, a critical step to achieve good signal quality and adhesion is to ensure the skin is prepared by shaving, abrading and cleaning with alcohol pads.This step may contribute to skin irritation and/ or itching while wearing the device.

Event Description

The patient reported an issue wherein they were treated at an emergency room facility to have the device removed due to skin irritation.Following the event, the probable allergic contact dermatitis with signs of secondary infection was medically treated by an er and primary physician.

• Brand Name: ZIO AT PATCH
• 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; 11085 knott avenue suite b; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103 ; 9494132147
• MDR Report Key: 14047316
• MDR Text Key: 292817454
• Report Number: 3007208829-2022-00032
• 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: 03/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 09/06/2022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Date Manufacturer Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2022
• 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): Other; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female