FDA.reportPublic FDA data

MAUDE MDR 12500

MDR report key
12500
Report number
MW1001411
Event key
0
Event type
3
Date of event
1994-03-11
Date received
1994-04-01
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
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
1KINCOMEXERCISE MACHINECHATTANOOGA GROUPIKK500HNY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
11994-04-0101. O

Event Narratives#

D

Patient 1

PT WAS ON THE EXERCISE MACHINE IN OUTPATIENT THERAPY, (WORK HARDENING PROGRAM), IN THE SEATED POSITION WITH THE LEVER ARM IN FRONT OF HER CHEST. THE LEVER ARM MOVED UNEXPECTEDLY AND PUSHED THE PT BACKWARD. PT DENIED INJURY AND DID NOT WISH TO SEE PHYSICIAN. ON 3/14/94 THERAPIST CALLED PT; PT REPORTED INCREASED SORENESS IN BACK EXTENSION AND WAS SEEN BY MD THAT DAY. ON 3/21/94 PT HAD FOLLOW-UP APPOINTMENT. X-RAY NEGATIVE; MISSED ONE-HALF WEEK OF TREATMENT BUT THIS DID NOT JEOPARDIZE HER PROGRAM. EQUIPMENT WAS SHUT DOWN IMMEDIATELY, CO CONTACTED AND SAID RELAY IN EQUIPMENT WAS BAD. MFR SENT PERSON TO REPAIR.