FDA.reportPublic FDA data

MAUDE MDR 532560

MDR report key
532560
Report number
532560
Event key
0
Event type
3
Date of event
2004-06-15
Date received
2004-06-29
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
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
1HYDROCULATOR*CHATTANOOGA PHARMACAL COIMA552**N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-06-2901. O

Event Narratives#

D

Patient 1

HOT MOIST PACK APPLIES ON LEFT KNEE BY RNA. AREA INSPECTED AFTER 8 MINUTES AND NOTED TO BE RED AND SKIN CAME OFF.