MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC. Zio Monitor; Recorder, Magnetic Tape, Medical

Model Number	DFG0001
Medical Device Problem Codes	Gel Leak (1267); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Itching Sensation (1943); Burning Sensation (2146); Skin Inflammation/ Irritation (4545)
Date of Event	08/18/2026
Type of Reportable Event	Malfunction
Event or Problem Description
I was prescribed this device from my neurologist i had it on for two days and it was so itchy and irritable, it almost felt like it was brining me.I was just in the hospital and had adhesives on me and had no reaction to them.With the ziopatch, on the second day, it started leaking a black gel and then i got a bad burning sensation.I used the adhesive remover wipe immediately and took it off to see it had burnt my skin.| udi: (b)(4) (zio monitor recorder, magnetic tape, medical).

• Brand Name: Zio Monitor
• Common Device Name: Recorder, Magnetic Tape, Medical
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 50410091
• Report Number: MW6001397
• Device Sequence Number: 18401688
• Product Code: DSH
• UDI-Device Identifier: 00869770000241
• UDI-Public: 00869770000241
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 08/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DFG0001
• Device Lot Number: DFF3283FPF
• Is the Reporter a Health Professional?: No
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/24/2026
• Patient Sequence Number: 1
• Patient Sex: Unknown