MAUDE Adverse Event Report: BIO TELEMETRY, INC. / BRAEMAR MANUFACTURING, LLC MCOT PATCH; ELECTRODE, ELECTROCARDIOGRAPH

Model Number KIT ID: 2905753

Device Problems Premature Discharge of Battery (1057); Component Missing (2306); Physical Resistance/Sticking (4012); Inaccurate Information (4051)

Patient Problems Abrasion (1689); Rash (2033)

Event Date 09/21/2020

Event Type  Injury  

Event Description

Mcot biotel heart monitor.Many problems.Kit was missing components and instructions were wrong.Developed skin rash from adhesive patch.Then switched to wired leads.These were ok until one of the lead patches that i used last time seemed to have faulty adhesive which would not come off skin.When i called biotel, the agent named (b)(6) could not find my record from name, or birthdate (although my info was in their system) so he couldn't help me.So i was on my own to remove the adhesive - i used soap and water - which did not work.It required so much rubbing - and pulling at the adhesive that it removed the skin.Later i called again and spoke to a supervisor who said to use soap and water.Also, this is the second time i was told to use a scrubby pad that was to have been included in the kit.I had told someone a week earlier that the scrubby pad was not included.They could have sent me one, but they did not.Also, this is the second time they told me to take a break in the service and resume a 1.5 days later - both times reducing the total testing time (even though they added 1 day).So in the end, if i can resume, they will be charging for 14 days service while only monitoring for 13 days.I know the doctors did not want to use the device from this company, but it must be the least expensive and was the only one covered by insurance.Now i am supposed to restart tomorrow - however it seems unwise to put a patch on an area where skin was abraded away due to faulty product and dangerously poor customer service.Furthermore the instructions included with the unit did not match what was included in the box, nor the way the device works - saying the monitor needs recharging every 5-7 days when actually it is necessary every 2 days - plus the battery was nearly dead when it was first attached to me.Also, they clearly never trained the technician in the doctors office how to use the device since she knew only the incorrect printed information.On (b)(6) 2020 is the date the test commenced.It was to have run for 2 weeks but has been interrupted two times so far due to problems.Fda safety report id# (b)(4).

• Brand Name: MCOT PATCH
• Type of Device: ELECTRODE, ELECTROCARDIOGRAPH
• Manufacturer (Section D): BIO TELEMETRY, INC. / BRAEMAR MANUFACTURING, LLC
• MDR Report Key: 10579621
• MDR Text Key: 208571227
• Report Number: MW5096836
• 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: 09/22/2020

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KIT ID: 2905753
• Device Catalogue Number: SEE PHOTOS FOR MODEL & LOTS
• Device Lot Number: U200228
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/23/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 68