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

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.

• Brand Name: JOHNSON & JOHNSON
• Type of Device: SHUNT NEUROSURG CSF SILICONE
• Manufacturer (Section D): JOHNSON & JOHNSON; wokingham RG40 3EW; UK RG40 3EW
• MDR Report Key: 5369707
• MDR Text Key: 36211549
• Report Number: MW5059361
• Device Sequence Number: 1
• Product Code: JXG
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 01/12/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SHUNT NEUROSURG CSF SILICONE
• Device Catalogue Number: NS0339
• Device Lot Number: 658527
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 14 MO
• Patient Weight: 14