*

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 NumberMW1040126
MDR Report Key755405
Date Received2006-08-22
Date of Report2006-07-25
Date of Event2005-12-21
Date Added to Maude2006-08-30
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NameULTRASONIC ASPIRATOR
Product CodeLBK
Date Received2006-08-22
Model Number*
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key743232
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2006-08-22

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