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

Model Number N100A102C

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Skin Irritation (2076)

Event Date 03/10/2016

Event Type  Injury  

Manufacturer Narrative

The instructions for use are provided to the clinic and includes 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 reported their skin was aggressively abraded by the applying technician in a localized area, in a manner they believed caused irritated skin.The patch was applied to the damaged skin, which led to further injury.The patient was admitted to the hospital where the patch was removed and a staphylococcus infection was diagnosed and then treated with intravenous antibiotics.

• Brand Name: ZIO XT PATCH
• Type of Device: ZIO PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 380; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC.; 650 townsend street; suite 380; san francisco CA 94103
• Manufacturer Contact: rich laguna ; 650 townsend street; suite 380; san francisco, CA 94103 ; 4156325749
• MDR Report Key: 5679845
• MDR Text Key: 45955865
• Report Number: 3007208829-2016-00002
• 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: Manufacturer
• Source Type: consumer
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2016
• Device Model Number: N100A102C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 52 YR