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ACCUDRAIN Adverse Event — Malfunction (MDR 2648988-2008-00008)

ACCUDRAIN Adverse Event — Malfunction (MDR 2648988-2008-00008) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACCUDRAIN; Generic name: NONE; Manufacturer: INTEGRA NEUROSCIENCES PR.

DeviceACCUDRAIN
Generic nameNONE
ManufacturerINTEGRA NEUROSCIENCES PR
Report number2648988-2008-00008
Event typeMalfunction
Product problemY
Date received2008-02-15
Report sourceHealth Professional, User facility
NarrativeON FEB 3, 2008 THE FOLLOWING INFO WAS PROVIDED. THE USER FACILITY IS UNSURE HOW LONG THE ACCUDRAINS WERE LEAKING BUT GUESSING WITHIN 2-4 HRS, BASED ON THE NURSES, ARE REQUIRED TO CHECK THE DRAIN AT A MIN OF EVERY 2 HRS. THE DEVICE WAS IN USE FOR SEVERAL DAYS BEFORE THE LEAKAGE WAS OBSERVED AND IT IS KNOWN THAT THIS FACILITY KEEPS THE DRAINS IN FOR 1-2 WEEKS DEPENDING ON THE PT'S NEED.
SourceopenFDA MAUDE (device adverse events)

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