FDA.reportPublic FDA data

MAUDE MDR 24224

MDR report key
24224
Report number
24224
Event key
0
Event type
3
Date of event
1995-01-06
Date received
1995-07-10
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
999
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
1TOURNIQUET MACHINETOURNIQUET MACHINEZIMMERDRPATS-1500604000-001NR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11995-07-1001. O

Event Narratives#

D

Patient 1

TOURNIQUET WAS PROPERLY PLACED ON PT'S RIGHT ARM AND THE CONNECTORS WERE TIGHTENED. MEDICATION WAS INJECTED. THE TOURNIQUET ALLOWED BLOOD FLOW INTO OPERATIVE SITE. THE TOURNIQUET HAD TO BE REMOVED AND A NEW ONE APPLIED. THE PT REQUIRED 7.5 CC 2% XYLOCAINE ADD'L MEDICATION, AND THE OR TIME WAS EXTENDED ABOUT 20 MINUTES.