MAUDE Adverse Event Report: VERMED, INC. VERSA TRODE; ELECTRODE, ELECTROCARDIOGRAPH

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Erythema (1840); Pain (1994); Rash (2033); Reaction (2414)

Event Date 05/03/2017

Event Type  No Answer Provided  

Event Description

I am writing to inform you of a serious allergic reaction i had after wearing a 48 hour holster heart monitor with your alleged "hypoallergenic ecg electrodes." on (b)(6) 2017 at 10:00 a.M.I was fitted with a 48-hour halter monitor at (b)(6).On (b)(6) 2017, i removed and returned the halter and alerted the staff at the front desk at (b)(6) about the rash on my chest.I was told that the electrodes were "hypoallergenic." apparently they are not as the painful, red and itchy rash on my chest can attest to.After suffering through the weekend ((b)(6)) following the removal of your electrodes, i was able to get an emergency appointment on (b)(6) with my dermatologist, dr.(b)(6).After explaining my situation and symptoms my dermatologist managed to squeeze me in for an appointment.In his past experience, he has seen where someone might get an irritation where the actual electrodes were placed.In my case he was surprised at the extent and location of the irritation.A steroid cream (fluocinonide 0.05%) was prescribed to be applied twice a day.Based on my experience i feel your product should be pulled from the marketplace or at the very least you should be prohibited from labeling it as "hypoallergenic." your claim of hypoallergenic is false and misleading.

• Brand Name: VERSA TRODE
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): VERMED, INC.; 400 exchange st.; global headquarters; buffalo NY 14204
• MDR Report Key: 6614300
• MDR Text Key: 76950034
• Report Number: MW5070187
• Device Sequence Number: 1
• Product Code: DRX
• 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: 05/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1