Model Number UCOR HEART FAILURE AND ARRHYTHMIA MANAGEMENT SYSTEM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bruise/Contusion (1754); Burning Sensation (2146); Discomfort (2330); Skin Inflammation/ Irritation (4545)
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Event Date 10/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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Biocompatibility testing to iso 10993 was successfully completed on skin-contacting surfaces.
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Event Description
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A us distributor contacted zoll to report that the patient developed a burning bruise from the ucor hfams patch.There was no alleged device malfunction contributing to the irritation.The patient¿s physician advised the patient to remove the device due to discomfort and skin irritation.Follow up indicated that the skin irritation improved.
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Search Alerts/Recalls
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