MAUDE Adverse Event Report: LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY

Model Number	MCT 1L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/28/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A dhr review was performed, with no contributing factors identified.The affected device has not been received by lifewatch services, inc.The patient reported sensitive skin / allergy described as "severe allergy".The patient was allegedly prescribed topicort by a healthcare provider.Based on information available the patient only wore the device for one day, and then did not want to continue.No new updates are available, the patient ended the enrollment.Skin irritation is a known inherent risk of the device.The mct-1l user guide (sup559 rev.D) includes warning statements stating the following: the mct 1lp is not intended for use on patients with skin orsoft tissue damage in the area where the patch is placed(such as burns, irritation, infections, wounds, etc.).If you develop a skin irritation, remove the mct 1lp and seek medical attention.Reddening or slight irritation of the skin from the mct 1lp is normal.Contact lifewatch services 1.800.517.6330 if you experience any irritation problems.The patient contacting materials of the patch system have been tested for cytotoxicity, sensitization and skin irritation per the following standards: cytotoxicity iso 10993-5, sensitization iso 10993-10, irritation iso 10993-10.No additional information is known to lifewatch services, inc.At this time.
Event or Problem Description
Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.
Additional Manufacturer Narrative
A dhr review was performed, with no contributing factors identified.The affected device has not been received by lifewatch services, inc.The patient reported sensitive skin / allergy described as "severe allergy".The patient was allegedly prescribed topicort by a healthcare provider.Based on information available the patient only wore the device for one day, and then did not want to continue.No new updates are available, the patient ended the enrollment.Skin irritation is a known inherent risk of the device.The mct-1l user guide (sup559 rev.D) includes warning statements stating the following: the mct 1lp is not intended for use on patients with skin orsoft tissue damage in the area where the patch is placed(such as burns, irritation, infections, wounds, etc.).If you develop a skin irritation, remove the mct 1lp and seek medical attention.Reddening or slight irritation of the skin from the mct 1lp is normal.Contact lifewatch services 1.800.517.6330 if you experience any irritation problems.The patient contacting materials of the patch system have been tested for cytotoxicity, sensitization and skin irritation per the following standards: cytotoxicity iso 10993-5.Sensitization iso 10993-10.Irritation iso 10993-10.No additional information is known to lifewatch services, inc.At this time.
Event or Problem Description
Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.

• Brand Name: LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY
• Common Device Name: LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY
• Manufacturer (Section D): LIFEWATCH SERVICES, INC.; 10255 w higgins rd.; suite 700; rosemont, il
• MDR Report Key: 9885388
• Report Number: 3027765-2020-00003
• Device Sequence Number: 2857502
• Product Code: DSI
• UDI-Device Identifier: 00850725007040
• UDI-Public: 00850725007040
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151269
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2020

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: MCT 1L
• Device Catalogue Number: MCT 1L: UNIVERSAL GATEWAY
• Device Lot Number: UNKNOWN/UNREPORTED
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: 03/02/2020
• Supplement Date Received by Manufacturer: 03/02/2020
• Initial Report FDA Received Date: 03/26/2020
• Supplement Report FDA Received Date: 05/14/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR