FDA.reportPublic FDA data

MAUDE MDR 572689

MDR report key
572689
Report number
572689
Event key
0
Event type
3
Date of event
2005-01-26
Date received
2005-02-11
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
U
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1UNKPARALLEL BAR*ILZ***N*

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12005-02-1101. O

Event Narratives#

D

Patient 1

PT USING PARALLEL BARS IN PHYSICAL THERAPY WHEN LEFT BAR SUDDENLY DROPPED. PT EXPERIENCED SUDDEN BEND FORWARD AND TO THE LEFT WITHOUT FALLING. PT REPORTED NEW INCIDENCE OF PAIN IN LOW BACK. BACK SPASMS WHEN TRANSFERRING TO W/C. DENIES NUMBNESS OR TINGLING IN BACK OR LEGS. EVALUATED IN ER.