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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES PR PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE
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INTEGRA NEUROSCIENCES PR PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE Back to Search Results
Catalog Number NL8501330
Device Problem Device Inoperable (1663)
Patient Problem Cerebrospinal Fluid Leakage (1772)
Event Date 07/24/2014
Event Type  malfunction  
Event Description
It was reported that a nl8501330 pudenz valve malfunctioned during a procedure.The event was described as follows; when connecting the outlet connector to the catheter, the surgeon had difficulty inserting it but, he managed to connect them.He then tried draining cerebrospinal fluid (csf) before completely implanting but, csf leaked from the connector.A "little" amount of csf was lost.They used another valve from stock.The incident caused a 20 minute delay.There was no pt harm.There was no info.Available about the pt's age, gender or underlying medical condition.
 
Manufacturer Narrative
To date, the device involved in the reported incident has not been received for eval.An investigation has been initiated based upon the reported info.
 
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Brand Name
PUDENZ VALVE, 16MM, BURR HOLE, LOW PRESSURE
Type of Device
NA
Manufacturer (Section D)
INTEGRA NEUROSCIENCES PR
anasco PR 00610
Manufacturer Contact
linda serentino
315 enterprise dr.
6099365560
MDR Report Key4043712
MDR Text Key16859045
Report Number2648988-2014-00040
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K760502
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 07/30/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/19/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberNL8501330
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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