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 12/03/2016

Event Type  Injury  

Manufacturer Narrative

The instructions for use are provided to the healthcare and include the following: warnings do not use the zio® xt patch on patients with known allergic reaction to adhesives or hydrogels or family history of adhesive skin allergies precautions: patients with sensitive skin or known skin conditions should use the zio® xt patch with caution.If irritation such as redness, severe itching or allergic symptoms (i.E.Hives) develop, instruct patients to remove the zio® xt patch immediately.

Event Description

The patient presented with probable contact dermatitis to their healthcare provider.The patient reported physician prescribed treatment.The manufacturer requested verification from both the patient and healthcare provider; however treatment was not confirmed.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 500; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 500; san francisco CA 94103
• Manufacturer Contact: rich laguna ; 650 townsend street; suite 500; san francisco, CA 94103 ; 4156325749
• MDR Report Key: 6206362
• MDR Text Key: 63337998
• Report Number: 3007208829-2016-00006
• 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: Patient
• Type of Report: Initial
• Report Date: 12/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/10/2017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2016
• Is the Device Single Use?: Yes
• 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: 29 YR