MAUDE MDR 937117

MDR report key
937117
Report number
3005009085-2007-00010
Event key
0
Event type
3
Date of event
2007-06-04
Date received
2007-11-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
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, LLCBASIC ROLLATORACCESS POINT MEDICAL, L.L.C.ITJUNK CURRENTLYUNK CURRENTLYNRN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-11-0201. O

Event Narratives#

D

Patient 1

PT WAS ISSUED A BASIC ROLLATOR OF ACCESS POINT MEDICAL THROUGH FIRST CHOICE MEDICAL SUPPLY. IN 2007, THE WHEELS ON THE WALKER MALFUNCTIONED CAUSING PT TO FALL INCURRING MULTIPLE INJURIES.

N

Patient 1

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