MAUDE Adverse Event Report: IRHYTHM TECHNOLOGIES, INC ZIO XT PATCH; ZIO PATCH

Device Problem Use of Device Problem (1670)

Patient Problem Skin Irritation (2076)

Event Date 11/06/2019

Event Type  Injury  

Manufacturer Narrative

Skin irritation is a known inherent risk of the device.Clinical ref.Manual (n100a4010.04) warnings state the following: do not use the zio xt patch on patients with known allergic reaction to adhesives or hydrogels or with family history of adhesive skin allergies.Patient may experience skin irritation.If skin irritation such as severe redness, itching or allergic symptoms develop, remove the zio xt patch from the patient's chest.

Event Description

The patient presented to their healthcare provider with a probable contact dermatitis where treatment was prescribed.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st; suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECH, INC; 11085 knott avenue; suite b; cypress CA 90630
• Manufacturer Contact: rich laguna ; 699 8th st; suite 600; san francisco, CA 94103 ; 4156325749
• MDR Report Key: 9398658
• MDR Text Key: 168821315
• Report Number: 3007208829-2019-00082
• Device Sequence Number: 1
• Product Code: DSH
• UDI-Device Identifier: 00869770000203
• UDI-Public: 00869770000203
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121319
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Date Manufacturer Received: 10/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR