MAUDE Adverse Event Report: LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)

Model Number MCT 3L

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/26/2020

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.Specific patient intrinsic, extrinsic, and preventable factors are unknown.No previously known skin sensitivities or allergies were reported by the patient.The patient allegedly consulted a clinician and was prescribed prednisone.The patient was also offered alternative electrodes that are more suitable for sensitive skin.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

Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.

Event Description

Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.

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.Specific patient instrinsic, extrinsic, and preventable factors are unknown.No previously known skin sensitivities or allergies were reported by the patient.The patient allegedly consulted a clinician and was prescribed prednisone.The patient was also offered alternative electrodes that are more suitable for sensitive skin.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.Nissha medical technologies/graphic controls investigated the event, including a review of the lot record paperwork, quality plans, and associated processes.This review found no nonconformances or anomalies.A trend report showed that there have not been any significant increases in skin reaction complaints over the past three years (lifewatch customer complaint reference cas - (b)(4)).The patient also used alternate cardinal health electrodes during the course of the enrollment.The supplier was notified of the event and lifewatch is awaiting supplier response regarding their evaluation.(lifewatch customer complaint reference cas - (b)(4)) no additional information is known to braemar manufacturing, llc at this time.

• Brand Name: LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)
• Type of Device: LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 3-LEAD ( UNIVERSAL GATEWAY)
• Manufacturer (Section D): LIFEWATCH SERVICES, INC.; 10255 w higgins rd.; suite 700; rosemont IL 60018 5606
• MDR Report Key: 11143062
• MDR Text Key: 228612969
• Report Number: 3027765-2021-00001
• Device Sequence Number: 1
• Product Code: DSI
• UDI-Device Identifier: 00850725007101
• UDI-Public: 00850725007101
• Combination Product (y/n): N
• PMA/PMN Number: K143359
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 09/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2021
• 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: MCT 3L: UNIVERSAL GATEWAY
• Device Lot Number: 3971V13
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR