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U.S. Department of Health and Human Services

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

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LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY Back to Search Results
Model Number MCT 1L
Device Problem Patient Device Interaction Problem (4001)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/17/2020
Event Type  Injury  
Manufacturer Narrative

A dhr review was performed, with no contributing factors identified. The affected device (patch) has not been received by lifewatch services, inc. The patient reported sensitive skin / allergy described as allergic to adhesive. The patient was allegedly prescribed a kenalog shot and triamcinolone. 1% cream (apply 3x a day). Based on information available the patient only wore the device for one day before experiencing skin irritation symptoms. 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 or soft 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 1l patch and seek medical attention. Reddening or slight irritation of the skin from the mct 1l patch 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 Description

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

 
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Brand NameLIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY
Type of DeviceLIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY
Manufacturer (Section D)
LIFEWATCH SERVICES, INC.
10255 w higgins rd.
suite 700
rosemont, il
Manufacturer (Section G)
LIFEWATCH SERVICES, INC.
10255 w higgins rd.
suite 700
rosemont, il
Manufacturer Contact
tahnee mehta
10255 w higgins rd.
suite 700
rosemont, il 
5312011
MDR Report Key10058343
MDR Text Key195645383
Report Number3027765-2020-00004
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK151269
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial
Report Date 05/14/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/14/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMCT 1L
Device Catalogue NumberMCT 1L: UNIVERSAL GATEWAY
Device LOT NumberUNKNOWN/UNREPORTED
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received04/22/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device?
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 05/14/2020 Patient Sequence Number: 1
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