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THERMOSONIC Adverse Event — Malfunction (MDR 10005092)

THERMOSONIC Adverse Event — Malfunction (MDR 10005092) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: THERMOSONIC; Generic name: MEDIA, COUPLING, ULTRASOUND; Manufacturer: PARKER LABORATORIES, INC..

DeviceTHERMOSONIC
Generic nameMEDIA, COUPLING, ULTRASOUND
ManufacturerPARKER LABORATORIES, INC.
Report number10005092
Event typeMalfunction
Product problemY
Date received2020-04-28
NarrativeAQUASONIC ULTRASOUND TRANSMISSION GEL WARMER MACHINE HAD WARMED THE GEL TOO HIGH WHERE THE NURSE'S LEFT HAND WAS BURNT WHEN USING IT. NO GEL CAME IN CONTACT WITH THE PATIENT. THE RN REQUIRED AN ICE PACK AFTER THE INCIDENT BUT DENIED ADDITIONAL MEDICAL TREATMENT. NO BLISTERING WAS REPORTED. THE WARMING UNIT WAS SEQUESTERED BY BIOMEDICAL ENGINEERING AND WAS TESTED. IT WAS HEATING TO 153 DEGREES F AN
SourceopenFDA MAUDE (device adverse events)

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