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

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Skin Irritation (2076)

Event Date 07/07/2015

Event Type  Injury  

Event Description

The patient wore the device for approx.3 days and presented with probable contact dermatitis and a secondary infection to their healthcare provider.Patient was prescribed an antibiotic for treatment.

• Brand Name: ZIO XT PATCH
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES INC.; san francisco CA
• Manufacturer Contact: rich laguna ; 650 townsend street; suite 380; san francisco, CA 94103-0000 ; 4156325700
• MDR Report Key: 4990677
• MDR Text Key: 22720466
• Report Number: 3007208829-2015-00005
• Device Sequence Number: 1
• Product Code: DSH
• 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: health professional
• Reporter Occupation: Nurse
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR