FDA Adverse Event Injury Summary report: N

ZIO XT

MDR report key: 11796951 · Received May 7, 2021

Report

Report Number
MW5101249
Event Type
Injury
Date Received
May 7, 2021
Date of Event
April 11, 2021
Report Date
May 5, 2021
Manufacturer
IRHYTHM TECHNOLOGIES, INC.
Product Code
DSH
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
AK, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

ADHESIVE ADVERSE REACTION; I WAS USING A ZIO PATCH HEART MONITOR, APPLIED (B)(6) 2021. IT STARTED ITCHING WITHIN AN HOUR OR SO. BY (B)(6) 2021 IT WAS ITCHING A LOT, AND MY FACE WAS SWELLING AND TURNING RED. I WENT TO THE ER AND WAS TREATED WITH BENADRYL AND FAMOTIDINE. I REMOVED THE ZIO PATCH AT THE ER. OVER THE COURSE OF THE NEXT WEEK I DEVELOPED HIVES AND SEVERE ITCHING AT THE ATTACHMENT SITE, AND ON MY ARMS, HEAD FACE AND TORSO. I VISITED MY PCP ON (B)(6) 2021 AND SHE PRESCRIBED BETAMETHASONE FOR ONE WEEK AS NEEDED, WHICH I USED. THE HIVES AND ITCHING DID NOT BEGIN TO IMPROVE UNTIL THE FOLLOWING WEEK - AROUND (B)(6) 2021. I CONTINUED TO TAKE BENADRYL AND FAMOTIDINE FOR THE NEXT FEW WEEKS, STOPPING BENADRYL ABOUT (B)(6) 2021. TODAY IS (B)(6) 2021 AND I AM STILL ITCHING, THE SKIN TEXTURE WHERE THE PATCH WAS APPLIED HAS CHANGED, AND I STILL HAVE A RASH, BUT IT DOES NOT ITCH. NOTE THAT I STARTED A MEDROL PACK ON (B)(6) 2021 SO THERE IS SOME QUESTION REGARDING WHAT CAUSED MY FACIAL SWELLING BUT GIVEN THE RASH THAT I ENDED UP WITH IT IS CLEAR TO ME THAT THE PATCH IS WHAT CAUSED MY PROBLEM. I DO HAVE A HISTORY OF POOR REACTION TO ADHESIVES. A COUPLE OF YEARS AGO I HAD A SYSTEMIC REACTION TO A LIDOCAINE PATCH WHICH I ATTRIBUTED TO A LIDOCAINE RESPONSE, BUT IN RETROSPECT (AFTER THIS RECENT EPISODE) I AM WONDERING IF IT WAS THE ADHESIVE IN THE PATCH INSTEAD, AND NOT THE LIDOCAINE. FDA SAFETY REPORT ID # (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
684827 ZIO XT RECORDER, MAGNETIC TAPE, MEDICAL DSH IRHYTHM TECHNOLOGIES, INC.

Patients

Seq Age Sex Outcome Treatment
1 66 YR Other| R