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U.S. Department of Health and Human Services

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

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BRAEMAR MANUFACTURING, LLC LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR Back to Search Results
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)).

 
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Brand NameLIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
Type of DeviceLIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
Manufacturer (Section D)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan, mn MN 55121
Manufacturer (Section G)
BRAEMAR MANUFACTURING, LLC
1285 corporate center drive
suite 150
eagan, mn MN 55121
Manufacturer Contact
beverly okoh
1285 corporate center drive
suite 150
eagan, mn, MN 55121
MDR Report Key8945876
MDR Text Key160844468
Report Number2133409-2019-00010
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
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 Received08/29/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMCT 3L
Device Catalogue NumberUNIVERSAL GATEWAY - VERIZON
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/20/2019
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/17/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 08/29/2019 Patient Sequence Number: 1
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