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

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	03/13/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint revealed that the patient wore the zio monitor for the full 7-day prescribed wear period.The patient had active acne at the device application site.The reported skin irritation was a result of exfoliation during skin preparation and not the zio monitor device.The patient has sensitive skin and a known history of reaction to medical adhesive.The device manual's preparing the skin section reads as follows: do not proceed to the next step (shaving and exfoliating) if the skin has the following conditions: an active skin rash, an active ongoing sensation of burning or stinging, a visible skin injury/broken skin, or skin with damage and a discharge of clear fluid or pus.In addition, the device manual provides guidance if a nick or cut should occur, treat the site and only continue once bleeding has stopped.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 reported skin irritation that occurred during the skin preparation process for the zio monitor device.During skin preparation, the patient shaved and exfoliated over pre-existing acne, resulting in bleeding, redness, and bumps.According to the patient, they treated with over-the-counter neosporin and later presented to a dermatologist in which they were prescribed triamcinolone acetonide.The device was applied a week later without further reported skin irritation.

• 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: 25117048
• Report Number: 3007208829-2026-00174
• Device Sequence Number: 10279883
• Product Code: DSH
• UDI-Device Identifier: 00869770000241
• UDI-Public: (01)00869770000241(17)260803
• Combination Product (Y/N): N
• 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): 05/07/2026

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: 08/03/2026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/17/2026
• 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 Age: 79 YR
• Patient Sex: Male