MAUDE Adverse Event Report: LIFEWATCH SERVICES, INC. ACT 3-LEAD MCT; SENSOR

Model Number ACT 3-LEAD MCT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 02/09/2022

Event Type  Injury  

Manufacturer Narrative

The patient consulted a clinician and complained that the device electrodes were making his skin bumpy and bloody.The physician prescribed hydrocortisone ointment to apply to the affected area.The patient decided to return the actual device early and did not continue enrollment.Patient did not return electrodes.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 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 lifewatch services, inc.At this time.

Event Description

Patient communication of consulting a healthcare professional stating that the electrodes were making the skin bumpy and bloody.

• Brand Name: ACT 3-LEAD MCT
• Type of Device: SENSOR
• Manufacturer (Section D): LIFEWATCH SERVICES, INC.; 10255 w higgins rd.; suite 700; rosemont IL 60018 5606
• Manufacturer (Section G): LIFEWATCH SERVICES, INC.; 10255 w higgins rd; suite 700; rosemont IL 60018 5606
• Manufacturer Contact: derrick massuri ; 10255 w higgins rd; suite 700; rosemont, IL 60018-5606 ; 4845312011
• MDR Report Key: 13684493
• MDR Text Key: 286846665
• Report Number: 3027765-2022-00005
• Device Sequence Number: 1
• Product Code: DSI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: ACT 3-LEAD MCT
• Device Catalogue Number: CARDGUARD LIFESTAR ACT3
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 62 YR
• Patient Sex: Male