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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IRHYTHM/ TECHNOLOGIES, INC. XIO XT PATCH RECORDER, MAGNETIC TAPE, MEDICAL

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IRHYTHM/ TECHNOLOGIES, INC. XIO XT PATCH RECORDER, MAGNETIC TAPE, MEDICAL Back to Search Results
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Abrasion (1689); Purulent Discharge (1812); Pain (1994); Scarring (2061); Skin Irritation (2076); Alteration In Body Temperature (2682)
Event Date 03/13/2018
Event Type  Injury  
Event Description

I was prescribed to wear the zio patch for 2 weeks. I was given no warning about potential reactions to the patch. At the office they abraded and then cleansed it with an alcohol prep pad before applying the device. This was quite painful and my skin was very red and irritated. The next morning i was still experiencing a lot of pain but i thought it was still due to the abrasion irritation. By the 27th hour of wearing it i noticed pus coming out from under the device. I called zio and was told that i could take the device off. No other instruction or help was given. I ended up running a fever that night because the wound was infected and had to go to my primary care doctor the next morning to receive an antibiotic. The wound did not heal and i have permanent scarring for the device. I am getting married this year so you can imagine that this is very upsetting that i was not warned about the risk of a reaction or possible scarring. I have worn other heart monitors with adhesives in the past and did not experience any irritation especially not pus and blistering like i did with the zio patch.

 
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Brand NameXIO XT PATCH
Type of DeviceRECORDER, MAGNETIC TAPE, MEDICAL
Manufacturer (Section D)
IRHYTHM/ TECHNOLOGIES, INC.
MDR Report Key7464036
MDR Text Key106730730
Report NumberMW5076741
Device Sequence Number1
Product Code DSH
Combination Product (Y/N)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 04/03/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator NO INFORMATION
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer?
Is The Device Single Use?
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient TREATMENT DATA
Date Received: 04/25/2018 Patient Sequence Number: 1
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