FDA.reportPublic FDA data

MAUDE MDR 148207

MDR report key
148207
Report number
148207
Event key
0
Event type
3
Date of event
1997-06-13
Date received
1998-01-09
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TCM3 TINA MONITORTRANCUTANEOUS OXYGEN MONITORRADIOMETER AMERICA INC.KLKTCM3-2**NY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11998-01-0901. R

Event Narratives#

D

Patient 1

PROBE FROM TRANSCUTANEOUS OXYGEN MONITOR BURNED CHEST RESULTING IN BLISTER. SETTING AT 43.5 DEGREES C.