MAUDE MDR 298289

MDR report key
298289
Report number
MW1020025
Event key
0
Event type
3
Date of event
1998-01-28
Date received
2000-09-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
305
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
1NONE KNOWNAXIAL LOADING JACKETLAFAYETTE ORTHODICTSIPTNANANANY

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12000-09-2601. S

Event Narratives#

D

Patient 1

A COMPRESSION DEVICE THAT WAS "THOUGHT UP" BY DR AND MADE BY ORTHOTIST WAS PLACED ON PT FOR A POST MYELOGRAM CAT SCAN. TORQUE AND APPLIED WEIGHT OF AN ESTIMATED 40% OF BODY WEIGHT WAS PLACED ON THE RIGHT SIDE OF PT'S BODY, FOLLOWED BY THE SAME ON THE LEFT. EVEN THOUGH PT COMPLAINED OF THE DISCOMFORT, THE DEVICE WAS KEPT ON THROUGHOUT THE PROCEDURE AND WAS REMOVED AT THE END DUE TO PT'S INSISTENCE BECAUSE OF THE UPPER BACK AND NECK PAIN. PT LATER FOUND THAT THIS WAS A HOMEMADE DEVICE AND THE PERSON PLACING THIS DEVICE WAS AN ORTHOTIST, NOT A PHYSICAL THERAPIST AS HE HAD STATED DURING THE APPLICATION. DR REFUSED TO ACKNOWLEDGE ANY OF THE COMPLAINTS OF PAIN AND UNEXPECTED/UNEXPLAINED DEFICIENCIES IN PT'S HEALTH POST THIS TEST. PT DID NOT SIGN ANY SORT OF RELEASE OR INFORMED CONSENT FOR THESE PERSONS TO USE THIS NON-APPROVED, EXPERIMENTAL DEVICE. PT WAS EXPERIENCING CONTINUED MIGRAINE HEADACHES, BLURRED VISION, WEAKNESS IN BILATERAL UPPER EXTREMITIES, LOSS IN HEIGHT OF APPROX 1 1/2 TO 2 INCHES, SHORTNESS OF BREATH, APPARENT SCOLIOSIS AND KYPHOSIS, EXTREME FATIGUE AND CONSTANT CHRONIC PAIN.