FDA.reportPublic FDA data

MAUDE MDR 35491

MDR report key
35491
Report number
35491
Event key
0
Event type
3
Date received
1996-07-13
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
1EDEC 80 X-RAY MACHINE AND CGRX-RAY MACHINE AND SPOT FILM DEVICEUNKITY***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11996-07-130

Event Narratives#

D

Patient 1

REPAIR TO COLLIMATOR AS SURGGESTED BY RADIATION PROTECTION. MEDICAL IMAGING SVC TECH REPAIRED COLLIMATOR.