MAUDE Adverse Event Report: IRHYTHM ZIO EVENT CARD MONITOR

Device Problem Insufficient Information (3190)

Patient Problem Rash (2033)

Event Date 08/01/2014

Event Type  Injury  

Event Description

I broke out in a rash from either the transmission gel or the adhesive on the electrode patches that came with my zio event card monitor.I lost use of the product for several days while i treated my rash with hydrocortisone creams (otc) and my cardiologist provided alternative pads that did not cause me to break out in a rash.The co refused to extend my 30 day use for the days lost to this adverse reaction to their product, so (b)(6) will be paying full price for 30 days when 30 days were not used.

• Brand Name: ZIO EVENT CARD MONITOR
• Type of Device: MONITOR
• Manufacturer (Section D): IRHYTHM
• MDR Report Key: 4064237
• MDR Text Key: 4858035
• Report Number: MW5038056
• Device Sequence Number: 1
• Product Code: LDD
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/18/2016
• Other Device ID Number: S/NE319-77-6252
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 47 YR
• Patient Weight: 98