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

Device Problem Use of Device Problem (1670)

Patient Problems Skin Infection (4544); Skin Inflammation/ Irritation (4545)

Event Date 03/07/2023

Event Type  Injury  

Manufacturer Narrative

On 14 mar 2023 the patient reported they were prescribed antibiotics due to a skin reaction with signs of secondary infection caused by additional adhesive tape used to secure zio xt.Skin irritation is a known inherent risk of the device.Device manual warnings section read as follows: 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.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 reported skin irritation with signs of secondary infection.The patient sought treatment from a health care provider, and antibiotics were prescribed.Per the patient, the cause of the allergic reaction was additional tape used to secure the device to the skin; the reaction was not caused by the patch itself.Information regarding the manufacturer of the tape is not available.

• Brand Name: ZIO XT
• Type of Device: RECORDER, MAGNETIC TAPE, MEDICAL
• Manufacturer (Section D): IRHYTHM TECHNOLOGIES, INC; 699 8th st suite 600; san francisco CA 94103
• Manufacturer (Section G): IRHYTHM TECHNOLOGIES, INC; 6550 katella avenue, suite 200; cypress CA 90630
• Manufacturer Contact: mazi kiani ; 699 8th st suite 600; san francisco, CA 94103
• MDR Report Key: 16695892
• MDR Text Key: 312855233
• Report Number: 3007208829-2023-00022
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 07/31/2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2023
• Date Manufacturer Received: 03/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• 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: 71 YR
• Patient Sex: Female