MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO MONITOR; RECORDER, MAGNETIC TAPE, MEDICAL

Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	04/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint revealed that the patient wore the zio monitor for 1 of the 7-day prescribed wear period.The patient does have sensitive skin and does not have a history of reaction to medical adhesive.While the cause of the reported event cannot be determined, the patient¿s preexisting sensitivity cannot be ruled out as a contributing factor.Skin irritation is a known inherent risk of the device.The device manual warnings section read as follows: do not use the zio monitor on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.If allergic symptoms, severe skin irritation, or signs of skin infection develop, remove the device from the patient¿s chest and discontinue wear.Reaction to adhesives may include severe redness and itching, hives, and blisters.Contact your healthcare provider and customer care to report the reaction.This event is being reported per 21cfr803 as a serious injury.This report does not constitute an admission by rhythm 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 or Problem Description
The patient presented to their healthcare provider (hcp) with skin irritation allegedly caused by the zio monitor.The patient reported redness, itching, hives, discomfort, swelling, and blistering at and around the adhesive application site.Prior to the clinic visit, the patient applied a cold compress to the affected area, which provided temporary relief.The patient was subsequently evaluated by an hcp and prescribed a topical steroid cream for treatment.

• Brand Name: ZIO MONITOR
• Common Device Name: RECORDER, MAGNETIC TAPE, MEDICAL
• 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: tara mackinnon ; 699 8th st suite 600; san francisco, CA 94103 ; 6094600577
• MDR Report Key: 25148602
• Report Number: 3007208829-2026-00187
• Device Sequence Number: 13064691
• Product Code: DSH
• UDI-Device Identifier: 00869770000241
• UDI-Public: (01)00869770000241(17)260812
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K202359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/12/2026

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/12/2026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female