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

Model Number ZIO XT PATCH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Blister (4537); Swelling/ Edema (4577)

Event Date 02/06/2021

Event Type  Injury  

Event Description

Patient described having "swelling" or "blistering" on site of adhesive.The site was pinkish reddish and resolved on (b)(6) 2021.No labs were done per study protocol.Therapy start date: (b)(6) 2021, end date: (b)(6) 2021.Fda safety report id# (b)(4).

• Brand Name: ZIO XT PATCH
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC. ; san francisco CA 94103
• MDR Report Key: 11332865
• MDR Text Key: 232221488
• Report Number: MW5099399
• Device Sequence Number: 1
• Product Code: DSH
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ZIO XT PATCH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR