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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JOHNSON & JOHNSON JOHNSON & JOHNSON SHUNT NEUROSURG CSF SILICONE

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JOHNSON & JOHNSON JOHNSON & JOHNSON SHUNT NEUROSURG CSF SILICONE Back to Search Results
Model Number SHUNT NEUROSURG CSF SILICONE
Device Problem Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/09/2016
Event Type  Injury  
Event Description
Shunt malfunction required replacement.
 
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Brand NameJOHNSON & JOHNSON
Type of DeviceSHUNT NEUROSURG CSF SILICONE
Manufacturer (Section D)
JOHNSON & JOHNSON
wokingham RG40 3EW
UK RG40 3EW
MDR Report Key5369707
MDR Text Key36211549
Report NumberMW5059361
Device Sequence Number1
Product Code JXG
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/12/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberSHUNT NEUROSURG CSF SILICONE
Device Catalogue NumberNS0339
Device Lot Number658527
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 01/12/2016 Patient Sequence Number: 1
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