FDA.reportPublic FDA data

MAUDE MDR 755453

MDR report key
755453
Report number
MW1040131
Event key
0
Event type
3
Date of event
2005-10-26
Date received
2006-08-22
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1*ULTRASONIC ASPIRATOR*LBK***NN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12006-08-2201. R

Event Narratives#

D

Patient 1

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-OPERATIVELY AND WAS DISCHARGED HOME 2 DAYS LATER. LATER SHE DEVELOPED A SUBCUTANEOUS COLLECTION OF FLUID AT THE SURGERY SITE WITH DELAYED WOUND HEALING. 9 DAYS LATER, SHE WAS TAKEN BACK TO SURGERY FOR CLOSURE OF THE WOUND. TWO DAYS LATER, SHE WAS DISCHARGED HOME IN STABLE CONDITION.