FDA.reportPublic FDA data

MAUDE MDR 2876917

MDR report key
2876917
Report number
2876917
Event key
0
Event type
3
Date of event
2012-11-09
Date received
2012-11-14
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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
1SONIALVISION VERSA 100R/100 DAR 8000ITABLE, RADIOGRAPHIC, NON-TILTING, POWEREDSHIMADZU MEDICAL SYSTEMSIZZ**OP11502005N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12012-11-140

Event Narratives#

D

Patient 1

PATIENT WAS UNDERGOING A DYSPHAGIA STUDY, SINCE THIS PATIENT WAS AMBULATORY, THE PATIENT WAS ALLOWED TO SIT ON THE FOOT BOARD IN AN UPRIGHT POSITION FOR THE TEST. THE RADIOLOGY TECH TESTED (SAT ON) THE FOOT BOARD PRIOR TO THE PATIENT SITTING ON IT AND IT TESTED FINE. AS THE PATIENT SAT ON THE FOOT BOARD FOR THE SCOUT IMAGE, SHE IMMEDIATELY FELL TO THE FLOOR. THE PATIENT DID STRIKE HER SIDE, BUT X-RAYS OF THE RIBS WERE NEGATIVE FOR FRACTURE.