MAUDE MDR 937118

MDR report key
937118
Report number
3005009085-2007-00011
Event key
0
Event type
3
Date of event
2006-07-17
Date received
2007-11-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
600
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
TAMMI SEELE- CONTROLLER
Address
PO BOX 411783 ST. LOUIS MO 63141 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCESS POINT MEDICAL, LLCPOWERCHAIRPHSIANGITIAXS-8000AXS-8000NRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-11-020

Event Narratives#

D

Patient 1

IN 2006, PT WAS OPERATING THE AXS-8000 ON A RAMP IN FRONT OF HER HOME WHEN IT TIPPED OVER BACKWARDS CAUSING HER TO SUSTAIN VARIOUS PERSONAL INJURIES.

N

Patient 1

IF PRODUCT IS RETURNED OR ADDITIONAL INFORMATION IS RECEIVED, WE WILL SUBMIT AN UPDATED MDR REPORT AT THAT TIME.