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 Infection (4544)
Date of Event	03/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the complaint revealed that the patient wore the zio monitor for 11 of the 14 prescribed days.The patient had sensitive skin and a known history of reactions to medical adhesives.A medical assessment by irhythm¿s chief medical safety officer concluded that the reported event is most consistent with non-infectious skin irritation rather than a device-related infection.Although small quantities of stenotrophomonas maltophilia were identified through biopsy, this organism is commonly found as normal skin flora, and the findings were not indicative of an active infectious process.The patient also reported not showering during the first several days of device wear, which may have contributed to localized skin irritation and bacterial colonization.Overall, the event was assessed as consistent with a known skin irritation adverse event associated with prolonged device wear, rather than a direct infectious effect of the adhesive or device itself.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 reported seeking evaluation from a dermatologist for skin irritation at the zio monitor device application site.The symptoms included itching, redness, and a burning sensation, along with welts and hives extending from the chest to the neck.A biopsy was performed, and the patient tested positive for stenotrophomonas maltophilia.The patient was prescribed levofloxacin tablets and triamcinolone acetonide cream as 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: 25210589
• Report Number: 3007208829-2026-00172
• Device Sequence Number: 18734245
• Product Code: DSH
• UDI-Device Identifier: 00869770000241
• UDI-Public: (01)00869770000241(17)260812
• 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): 05/18/2026

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: 04/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Initial Report FDA Received Date: 05/18/2026
• 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 Age: 39 YR
• Patient Sex: Female