MAUDE MDR 786114

MDR report key
786114
Report number
786114
Event key
0
Event type
3
Date of event
2005-05-20
Date received
2005-06-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CODMANDISPOSABLE PERFORATORCODMANKATNANADX821NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-06-2701. L; 2. R

Event Narratives#

D

Patient 1

ADMITTED FROM ANOTHER ACUTE CARE FACILITY IN 2005 AFTER FALL. DIAGNOSED WITH A LARGE RIGHT ACUTE SUBDURAL HEMATOMA WITH MINOR CHRONIC COMPONENT. PRIOR TO SURGICAL INTERVENTION AT THIS FACILITY, THE PT'S COAGULOPATHY WAS REVERSED WITH FFP, PLATELETS, AND INTRAVENOUS DDAVP. IN 2005 AN OPERATIVE EVACUATION OF THE SUBDURAL HEMATOMA BY STANDARD CRANIOTOMY WAS PERFORMED. THE FIRST TWO BURR HOLES WERE CREATED WITHOUT DIFFICULTY WHILE CREATING THE THIRD BURR HOLE POSTERIORLY, THE DUAL PERFORATED BIT, BUT NOT STOP. THE DRILL WAS PREVENTED FROM PLUNGING DEEP BY THE SURGEON'S HANDS, BUT NONE THE LESS A LACERATION OF THE DURA AND A SMALL CORTICAL LACERATION OCCURRED. THE REGION WAS INSPECTED, IRRIGATED, ELECTRO-CAUTERIZED, AND A LITTLE BIT OF GEL FOAM WAS PLACED. THERE DID NOT APPEAR TO BE ANY MAJOR INTRAPARENCHYMAL HEMORRHAGE AT THAT LEVEL, NOR ANY BRAIN SWELLING. AS THE SURGERY PROGRESSED BRAIN SWELLING OCCURRED. THE LEVEL OF THE THIRD BURR HOLE WAS RE-EXPLORED, BUT NO OBVIOUS INTRAPARENCHYMAL HEMATOMA WAS SEEN, BUT RATHER SWOLLEN WHITE MATTER. DUE TO THIS MALIGNANT BRAIN SWELLING, AN IMMEDIATE FRONTAL AND TEMPORAL LOBECTOMY WAS DONE. AFTER COMPLETION OF SURGERY THE, PT WAS TAKEN TO THE CT SCANNER AND THEN TO THE ICU.