MAUDE Adverse Event Report: GRAPHIC CONTROLS ACQUISITION CORP. VERMED; ELECTRODE, ELECTROCARDIOGRAPH

Model Number REF A10091-5

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Hemorrhage/Bleeding (1888); Pain (1994); Burning Sensation (2146); Discomfort (2330); Reaction (2414)

Event Date 05/11/2018

Event Type  Injury  

Event Description

My cardiologist prescribed the "cardiokey extended holter monitoring" device for me.I began wearing it on (b)(6) 2018, and was instructed to wear it continuously for 14 days, changing the electrode patches every other day.I had told the nurse who gave me instructions on using the device that i had had skin reactions to wearing patches in the past, and that i was very concerned about wearing the adhesive-coated electrodes for 2 weeks, putting them back in the same place on my chest every time they were changed.I was reassured that the "holter" was "hypoallergenic" and would "not be a problem." by (b)(6) 2018, after wearing the electrodes for 7 days, my skin had developed blisters under the electrodes.By (b)(6) 2018, those blisters had started weeping.Because it had been strongly emphasized that the information gained from the "holter" was "very important to [my] health," i continued to wear the device in spite of the constant burning pain.At the end of the 2-week period, the two places on my chest where the electrodes had been were bright red, blistered, and in one case, actually bleeding.Not my cardiologist, his nurse, nor the company producing the "holter" gave me any indication in any form that this device might cause such pain and discomfort.If needed, i have photos available that were taken on a couple of different days.I did call my cardiologist's office and left a voice message with his primary nurse (actually getting to speak to either the doctor or his nurse required far more time and patience than i had on that day.) i did not ask for a call back, so i do not know if the nurse documented the skin issue in my records.The manufacturer, biotelemetry, should be required to inform users that the adhesive can cause serious burn-like places under the electrode patches after several days of wearing them.The actual patches are made by "(vermed a graphic controls company", and are simply described as ecg monitoring electrodes, noting on the packaging that they are hypoallergenic.I strongly suspect that description is for the one-time, short duration use during an ecg with a professional health care providers oversight, not continuous use as is required in the holter application.

• Brand Name: VERMED
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): GRAPHIC CONTROLS ACQUISITION CORP.
• MDR Report Key: 7549044
• MDR Text Key: 109633381
• Report Number: MW5077476
• Device Sequence Number: 1
• Product Code: DRX
• UDI-Device Identifier: 70813150021615
• UDI-Public: (01)70813150021615(17)190824(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: REF A10091-5
• Device Lot Number: 34617V11
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 64