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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

[532150] This is a female that had a decompressive laminectomy done in 2005. An ultrasonic aspirator was used during the surgery. Initially she did well post-opertively and was discharged home three days later. Later she developed leakage of fluid at the surgery site. Thirty-seven days after discharge, she was taken back to surgery for repair of a dural laceration. Three days later, she was discharged home in stable condition.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1040130
• MDR Report Key: 755437
• Date Received: 2006-08-22
• Date of Report: 2006-07-05
• Date of Event: 2005-11-28
• 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: 743264
• Manufacturer: *
• Manufacturer Address: * * *

Patients

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