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

Device Problem Use of Device Problem (1670)

Patient Problems Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943); Urticaria (2278); Discomfort (2330)

Event Date 02/09/2023

Event Type  Injury  

Event Description

Zio xt heart monitor was placed on (b)(6) 2023.It was slightly itchy and uncomfortable working a few hours.By day 6 i woke up with head to toe hives.Large hives.Took monitor off.On (b)(6) 2023 hives were worse so i went to the er where i received treatment for the allergic reaction.It is now(b)(6) 2023 and i am still getting the hives, and now seeing an allergist to figure out what exactly i reacted to with the monitor.

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.
• MDR Report Key: 16487019
• MDR Text Key: 310795079
• Report Number: MW5115424
• Device Sequence Number: 1
• Product Code: DSH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: B12; BUSPIRONE; CALM MAGNESIUM SUPPLEMENT; CHLORPHENIRAMINE MALEATE; CORTISONE 10; RED YEAST RICE; VITAMIN D3
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White