FDA.reportPublic FDA data

MAUDE MDR 527630

MDR report key
527630
Report number
MW1032081
Event key
0
Event type
3
Date of event
2002-07-26
Date received
2004-05-14
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
1*COMPUTER DIAGNOSTIC SCREENING*HCCUNKUNKUNKNN

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12004-05-1401. L

Event Narratives#

D

Patient 1

PT HAD BEEN ASTHMATIC FOR OVER 20 YEARS. PT WAS TREATED FOR ASTHMA IN 2002 FOLLOWING A PNEUMONIA. PT WAS PUT ON PREDNISONE AND LEVAQUIN. PT LOST WEIGHT AND ENERGY AND HAD TO STOP THE STEROID. THEY TOOK SOLACE IN CHIROPRACTICE WHERE THE DEVICE WAS USED ON THEM AND THEY WERE TOLD THEY SCORED LOW WITH REGARDS TO THEIR HEART, PITUITARY, THYROID, NERVOUS SYSTEM AND WERE GIVEN A COMBINATION OF MEDICATIONS INCLUDING ACIDOPHIL, LYMPAO-LIQUIROPHIC, HYPO-GEST, DAILY COMPLETE; TRACE MINERALS, CATAPLEX ACP PNEUMO CAROTENE, LYMPHO-LIQUITROPHIC, HYPO-GEST, DAILY COMPLETE, TRACE MINERALS, CATAPLEX ACP, PNEUMO-CAROTENE. THE PT DID NOT FEEL BETTER. INSTEAD, THEIR ANKLE, CALVES AND FEET BECAME SWOLLEN AND THEY BECAME EXTREMELY WEAK. PT HAD BEEN RELUCTANT TO GO BACK TO THE DOCTOR FOR FEAR OF BEING PUT ON STEROIDS AND AT THE SAME TIME IS SCARED OF VISITING THE CHIROPRACTICE OFFICE BECAUSE THE LAST TIME THEY VISITED THE DOCTOR THEY HAD VIALS OF "STEM CELLS" IN THEIR REFRIGERATOR WHICH HE WANTED TO TEST ON PT BUT THEY REFUSED.