Model Number LIFEVEST WCD 4000 SYSTEM |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
Skin Inflammation/ Irritation (4545)
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Event Date 02/18/2024 |
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 of the lifevest device as well as the blue(tm) defibrillation gel.
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Event Description
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Patient reported multiple burns on the skin following an alleged treatment event.There is no indication that the patient received medical intervention.Patient reported applying antibiotic ointments and the burns healed.
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Search Alerts/Recalls
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