MAUDE MDR 1546759

MDR report key
1546759
Report number
3005009085-2009-00002
Event key
0
Event type
3
Date of event
2007-06-05
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
Address
PO BOX 66738 CHIEF OPERATING OFFICER 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 MEDICALWALKERACCESS POINT MEDICALITJWK42351-4LT043006R N

Patients#

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

Event Narratives#

D

Patient 1

PT HAS SUED (B)(6) BECAUSE SHE TRIPPED AND FELL UPON ENTERING THE (B)(6). (B)(6) HAS IN TURN SUED ACCESS POINT MEDICAL ALLEGING PT WAS USING A WALKER MFG BY ACCESS POINT MEDICAL INC AT THE TIME OF THE TRIP AND FALL.

N

Patient 1

IF PRODUCT IS RETURNED OR ADD'L INFO IS REC'D, WE WILL SUBMIT AN UPDATED MDR REPORT AT THAT TIME.