MAUDE Adverse Event Report: BRAEMAR MANUFACTURING, LLC LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

Model Number MCT 3L

Device Problems Insufficient Information (3190); Patient Device Interaction Problem (4001)

Patient Problems Skin Irritation (2076); Irritability (2421)

Event Date 08/04/2019

Event Type  Injury  

Manufacturer Narrative

Per patient user guide sup546, patients are provided warning statements regarding electrode skin irritation.Patients are instructed to contact lifewatch services customer support prior to using the mct 3l monitoring system if they have known allergies to nickel or other metals.The patient is also informed in the user guide that if they develop skin irritation they should contact their healthcare professional.The patient described the experienced skin irritation as redness, itching, blisters, and welts and swelling of the tongue.The patient indicated that the irritation primary location was the entire electrode area.Other than allergy to nickel, specific patient intrinsic, extrinsic, and preventable factors are unknown.The patient did not consult a clinician and self-treated with benadryl (otc), with no further deterioration.The patient did not seek or receive medical treatment.The patient had started monitoring on (b)(6) 2019, irritation started on (b)(6) 2019 and reported on (b)(6) 2019.The patient was provided alternate electrodes on (b)(6) 2019 and was able to continue monitoring with the new electrodes on (b)(6) 2019.The event is being reported in alignment with patient allegation of "swelling of the tongue".Device history record was reviewed, with no contributing factors identified.No additional information is known to braemar manufacturing, llc at this time.

Event Description

On (b)(6) 2019, patient notified lifewatch services, inc.Of skin irritation/reaction.The symptoms described by the patient included "swelling of the tongue".Note: become aware date is (b)(6) 2019, per complaint case generated (cas - (b)(4)).

Manufacturer Narrative

Per patient user guide sup546, patients are provided warning statements regarding electrode skin irritation.Patients are instructed to contact (b)(4) customer support prior to using the mct 3l monitoring system if they have known allergies to nickel or other metals.The patient is also informed in the user guide that if they develop skin irritation they should contact their healthcare professional.The patient described the experienced skin irritation as redness, itching, blisters, and welts and swelling of the tongue.The patient indicated that the irritation primary location was the entire electrode area.Other than allergy to nickel, specific patient instrinsic, extrinsic, and preventable factors are unknown.The patient did not consult a clinician and self-treated with benadryl (otc), with no further deterioration.The patient did not seek or receive medical treatment.The patient had started monitoring on (b)(6) 2019, irritation started on (b)(6) 2019 and reported on 8/9/2019.The patient was provided alternate electrodes on 8/9/2019 and was able to continue monitoring with the new electrodes on (b)(6) 2019.The event is being reported in alignment with patient allegation of "swelling of the tongue".The patient was able to continue monitoring for another eight (8) days with alternative nickel free electrodes and no further issues reported afterwards.Device history record was reviewed, with no contributing factors identified.No additional information is known to braemar manufacturing, llc at this time.Customer complaint was relayed to electrode manufacturer (3m) and a response was provided indicating the following (redacted): the red dot electrodes have been subject to a 3m board certified toxicologist review and have been subject to biological testing to confirm they are safe for their acceptable use.In addition to performing clinical studies, 3m monitors its medical devices with manufacturing controls such as: 1) residual solvent release specifications and testing.2) adhesive basis weight controls.3) retain samples.4) function release specifications and testing.Despite these studies and controls, there is a percentage of the population who are sensitive or who may become sensitive to adhesive products.The patients may also have delicate skin type or sensitivity to skin prep materials.To monitor these situations, medical complaints are trended to allow for appropriate corrective action to be taken if the trend deviates from historical values.No additional contributing factors were identified upon review of the supplier response.No additional information is known to (b)(4), inc.At this time.

Event Description

On (b)(6) 2019, patient notified (b)(4), inc.Of skin irritation/reaction.The symptoms described by the patient included "swelling of the tongue".Note: become aware date is (b)(6) 2019, per complaint case generated ((b)(4)).

• Brand Name: LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
• Type of Device: LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
• Manufacturer (Section D): BRAEMAR MANUFACTURING, LLC; 1285 corporate center drive; suite 150; eagan, mn MN 55121
• MDR Report Key: 8979301
• MDR Text Key: 161922468
• Report Number: 2133409-2019-00011
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• PMA/PMN Number: K110499
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: MCT 3L
• Device Catalogue Number: ACT3 PLAT SENSOR / 3M RED DOT
• Device Lot Number: 202105HA
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/09/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR