LIFEWATCH SERVICES, INC. LIFEWATCH MOBILE CARDIAC TELEMETRY MCT 1-LEAD: UNIVERSAL GATEWAY
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Model Number MCT 1L |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 02/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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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 described as "severe allergy".The patient was allegedly prescribed topicort by a healthcare provider.Based on information available the patient only wore the device for one day, and then did not want to continue.No new updates are available, the patient ended the enrollment.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 orsoft 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 1lp and seek medical attention.Reddening or slight irritation of the skin from the mct 1lp 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.
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Event Description
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Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.
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Manufacturer Narrative
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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 described as "severe allergy".The patient was allegedly prescribed topicort by a healthcare provider.Based on information available the patient only wore the device for one day, and then did not want to continue.No new updates are available, the patient ended the enrollment.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 orsoft 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 1lp and seek medical attention.Reddening or slight irritation of the skin from the mct 1lp 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.
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Event Description
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Patient communication of consulting a healthcare professional due to allergic reaction/skin irritation where treatment was prescribed.
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