FDA.reportPublic FDA data

MAUDE MDR 8471389

MDR report key
8471389
Report number
2438477-2019-00017
Event key
0
Event type
3
Date of event
2019-03-18
Date received
2019-04-01
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
D
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1DRIVETRANSPORT CHAIRA & IINMTS19* Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12019-04-0101. H

Event Narratives#

D

Patient 1

(B)(4) IS THE INITIAL IMPORTER OF THE DEVICE WHICH IS A TRANSPORT CHAIR. THE END-USER SAT IN THE TRANSPORT CHAIR. THE BRAKE WAS ENGAGED; THE DEVICE WAS LOCKED. THE DEVICE IS MEANT TO BE PUSHED BY AN ATTENDANT. (B)(6) TRIED TO TURN THE CHAIR. IT WENT BACKWARDS AND FLIPPED OVER. HE HIT HIS HEAD ON THE PAVEMENT. HE WAS TRANSPORTED TO THE HOSPITAL BY EMS. FURTHER TESTS REVEALED A SPRAINED SHOULDER.