MAUDE MDR 1547594

MDR report key
1547594
Report number
3005009085-2009-00001
Event key
0
Event type
3
Date of event
2009-09-24
Date received
2009-11-23
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
TED DEINARD, OFFICER
Address
PO BOX 66738 ST. LOUIS MO 63166 US
Phone
877-877-8772
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ACCESS POINT MEDICALROLLATORACCESS POINT MEDICALITJRL10040A-RDR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-11-2301. O

Event Narratives#

D

Patient 1

PT ALLEGES SHE WAS SITTING IN ROLLATOR IN LINE AT THE FOOD STAMP OFFICE WHEN THE WHEEL CAME OFF. SHE REPORTS THAT SHE FELL AND BROKE HER SHOULDER.

N

Patient 1

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