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

Model Number ACT 3-LEAD

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 04/05/2022

Event Type  Injury  

Manufacturer Narrative

The patient consulted a clinician and complained that the device electrodes were causing red raised circles and skin irritation where the electrodes are placed.The physician prescribed triderm cream to apply to the affected area.The patient was offered alternative sensitive skin electrodes for monitoring period completion.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 they were experiencing red raised circles and skin irritation.

• Brand Name: ACT 3-LEAD
• 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: 14163454
• MDR Text Key: 289697609
• Report Number: 3027765-2022-00009
• 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: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• 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
• Device Catalogue Number: CARDGUARD LIFESTAR ACT3
• Device Lot Number: ELECTRODE LOT 202111011
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2022
• 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: 30 YR
• Patient Sex: Female