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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR

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LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR Back to Search Results
Model Number MCT 3L
Device Problem Patient Device Interaction Problem (4001)
Patient Problems Hypersensitivity/Allergic reaction (1907); Patient Problem/Medical Problem (2688)
Event Date 01/31/2020
Event Type  Injury  
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 and being highly allergic to latex. The patient went to the er due to skin irritation which she believes is a skin reaction due to the electrode she was using. A steroid cream was prescribed to the patient but she did not get the prescription filled. Instead the patient self-treated with cortisone cream she already had at home. Skin irritation is a known inherent risk of the device. The mct-3l user guide (sup546 rev. G) includes warning statements stating the following: minor skin irritation can occur with electrode use. Carefully, follow the instructions in this section. If skin irritation occurs, do not place the electrodes in the same location as the irritated skin. Instead, apply the replacement electrodes adjacent to the original sites to continue an accurate reading. If irritation worsens or becomes severe, contact lifewatch to obtain an alternative type of electrode. If there are questions regarding treating irritating skin, please contact your prescribing physician or health care professional. Alternative electrodes are available for patients with a history of sensitivity and/or allergy to adhesives by calling (b)(6).

 
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 3 LEAD ECG MONITOR
Type of DeviceLIFEWATCH MOBILE CARDIAC TELEMETRY 3 LEAD ECG MONITOR
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
tahnee mehta
10255 w higgins rd.
suite 700
rosemont, IL 60018-5606
4845312011
MDR Report Key9820058
MDR Text Key191271670
Report Number3027765-2020-00002
Device Sequence Number1
Product Code DSI
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110499
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type CONSUMER
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/10/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL NumberMCT 3L
Device Catalogue NumberACT3: 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 Hospital
Date Manufacturer Received02/11/2020
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: 03/11/2020 Patient Sequence Number: 1
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