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

Model Number MCT 3L

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 08/17/2019

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 "itching, swollen, redness rash and throat felt like it was closing." the patient indicated that the irritation primary location was beyond the electrode area.Specific patient instrinsic, extrinsic, and preventable factors are unknown.The patient indicated that they do not have sensitive skin or allergies.The patient consulted a clinician (observation/counseling) and was not prescribed medication for the symptoms, therefore no medical treatment is deemed to have been administered.The patient self-treated with over the counter (otc) benadryl lotion.The patient was also offered alternative electrodes that are more suitable for sensitive skin.The event is being reported in alignment with patient allegation of "throat felt like it was closing".The affected device was returned to lifewatch services, inc.On 08/20/2019.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 were described by the patient as "itching, swollen, redness rash and throat felt like it was closing." note: become aware date is (b)(4) 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 "itching, swollen, redness rash and throat felt like it was closing." the patient indicated that the irritation primary location was beyond the electrode area.Specific patient instrinsic, extrinsic, and preventable factors are unknown.The patient indicated that they do not have sensitive skin or allergies.The patient consulted a clinician (observation/counseling) and was not prescribed medication for the symptoms, therefore no medical treatment is deemed to have been administered.The patient self-treated with over the counter (otc) benadryl lotion.The patient was also offered alternative electrodes that are more suitable for sensitive skin.The event is being reported in alignment with patient allegation of "throat felt like it was closing".The affected device was returned to (b)(4), inc.On 08/20/2019 with no device factors identified.Device history record was reviewed, with no contributing factors identified.Electrode lot # was not available by the patient.The ifu located on the pouch states the electrodes are hypoallergenic and an electrode is to be worn for less than 72 hours.The electrodes are also pvc and latex free.The electrode supplier has not undergone changes in the production process or raw materials and meet requirements for skin sensitivity / cytotoxicity / irritation.No additional information is known to braemar manufacturing, llc at this time.

Event Description

On (b)(6) 2019, patient notified (b)(4), inc.Of skin irritation/reaction.The symptoms were described by the patient as "itching, swollen, redness rash and throat felt like it was closing." 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: 8945876
• MDR Text Key: 160844468
• Report Number: 2133409-2019-00010
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00850725007033
• UDI-Public: 00850725007033
• 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: 08/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• 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: UNIVERSAL GATEWAY - VERIZON
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Date Manufacturer Received: 08/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 41 YR