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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-08-22 for * manufactured by *.

Event Text Entries

[506477] This is a female that had a decompressive laminectomy done in 2005. An ultrasonic aspirator was used during the surgery. Intially she did well post-operatively and was discharged home two days later. Later she developed severe headaches and increased drainage from the surgery site. The next month, she was taken back to surgery for repair of a dural tear. She was discharged home in stable condition in the care of her family.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040126
• MDR Report Key: 755405
• Date Received: 2006-08-22
• Date of Report: 2006-07-25
• Date of Event: 2005-12-21
• Date Added to Maude: 2006-08-30
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: *
• Generic Name: ULTRASONIC ASPIRATOR
• Product Code: LBK
• Date Received: 2006-08-22
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 743232
• Manufacturer: *
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Required No Informationntervention	2006-08-22