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MAUDE MDR 5804

MDR report key
5804
Report number
5804
Event key
0
Event type
3
Date of event
1993-06-10
Date received
1993-07-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
0
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CODMANDISPOSABLE PERFORATORCODMAN & SHURLTEFFKATN/A261221DK815*Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11993-07-0101. O

Event Narratives#

D

Patient 1

WHILE USING A CODMAN DISPOSABLE PERFORATOR ON A CRANIOTOMY, A SAGITTAL SINUS TEAR WAS ENCOUNTERED AFTER THE PERFORATOR FAILED TO DISENGAGE AFTER PERFORATING THE PATIENT'S SKULLDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.