FDA.reportPublic FDA data

MAUDE MDR 11838

MDR report key
11838
Report number
MW1000957
Event key
0
Event type
3
Date of event
1994-02-09
Date received
1994-03-02
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
111
Health professional
3
Initial report to FDA
0
Event location
3

Manufacturer Contact#

Report source
P
Manufacturer link flag
N

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1KIN COMISOKINETIC EXERCISE AND TESTINGCHATTANOOGA GROUP, INC.IKK125E PLUSNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-03-0201. H; 2. O

Event Narratives#

D

Patient 1

THE PT WAS EXERCISING HER HAMSTRING MUSCLES IN THE PRONE POSITION ON THE DEVICE. THE RANGE OF MOTION WAS SET VIA THE COMPUTER FROM APPROX 10-80 DEGREES FLEXION. THE PT WAS SET UP BY THE PHYSICAL THERAPIST WITHOUT INCIDENT. HOWEVER, WHILE EXERCISING, THE PT NOTICED SOMETHING FELT LOOSE. SHE CALLED A PHYSICAL THERAPIST ASSISTANT AND WHEN THE ASSISTANT FOUND THAT THE LEVER ARM HAD BECOME LOOSE, SHE TIGHTENED IT. SHE THEN RESTARTED THE PROGRAM AND THE MACHINE MALFUNCTIONED, PULLING THE PT'S LEG QUICKLY AND SHARPLY INTO HYPEREXTENSION. THE PT REPORTED THE SCREEN FLASHED TO A DIFFERENT PROGRAM. THE ASSISTANT QUICKLY STOPPED THE DEVICE AND SEVERAL THERAPISTS ASSISTED HER IN UNSTRAPPING THE PT'S LEG AND ASSISTING HER OFF THE UNIT. IT IS UNKNOWN WHETHER THE MECHANICAL STOPS, WHICH WERE NOT PUT IN, WOULD HAVE STOPPED THE LEVER ARM.