FDA.reportPublic FDA data

MAUDE MDR 3226023

MDR report key
3226023
Report number
1419652-2013-00175
Event key
0
Event type
3
Date of event
2013-06-06
Date received
2013-07-05
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#

Address
50 NORTH GARY AVE., SUITE A ROSELLE IL 60172 US
Report source
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SARA PLUSNONEARJOHUNTLEIGH POLSKA SP. ZO.O.FRWHEP2001-UK Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-07-0501. H

Event Narratives#

D

Patient 1

ACCORDING TO THE COMPANY REPRESENTATIVE DESCRIPTION: 'THE PATIENT WAS BEING LIFTED INTO A STANDING POSITION USING THE SARA PLUS. ONCE IN THE STANDING POSITION THE PATIENT BECAME UNSTEADY. HE TRIED TO STEP OFF OF THE FOOT BOARD AND THEN COLLAPSED. IN AN ATTEMPT TO RELEASE HIM FROM THE SLING THE STAFF LET LOOSE THE SLING CORDS. HE THEN SLUMPED DOWN CATCHING HIS THROAT AGAINST ONE OF THE SLING CORDS. HE STARTED TO ASPHYXIATE AND THE CRASH TEAM WAS CALLED'.