FDA Adverse Event Injury Summary report: N

CALDIUM

MDR report key: 508834 · Received January 29, 2004

Report

Report Number
MW1030908
Event Type
Injury
Date Received
January 29, 2004
Date of Event
May 6, 2002
Report Date
January 7, 2004
Manufacturer
*
Product Code
GYB
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

IN CONNECTING THE WIRES TO PT'S HEAD THEY USED CALDIUM. A DRYER WAS USED TO DRY THE GLUE WHILE PT WAS BREATHING THE FUMES FROM THE GLUE. IT TAKES 45 MINUTES TO FINISH BUT IN PT'S CASE THEY HAD TO TAKE THE WIRES OUT AND DO IT OVER WHICH TOOK 1-1/2 HOURS WHICH GAVE THEM A DOUBLE DOSE OF THE FUMES; PT TOLD THEM THEY WERE GETTING SICK BUT THEY SAID IT WILL ONLY TAKE A FEW MORE MINUTES. THEY KNEW PT HAD ASTHMA WHICH HAS BEEN UNDER CONTROL SINCE 1998 AS A RESULT OF TAKING MSM AND PT DID NOT HAVE TO USE INHALER. PT WENT INTO SHOCK. PT WAS NOT IN ANY CONDITION TO DRIVE HOME THE NEXT MORNING WHICH COULD HAVE RESULTED IN AN ACCIDENT. PT WAS TOO SICK TO WASH THEIR HAIR AND IT TOOK SEVERAL DAYS TO GET THE GLUE OUT. THE NEXT DAY PT CAME DOWN WITH A DRY COUGH AND THEN PNEUMONIA. THE COUGH WAS AS BAD AS WHEN PT HAD THE HONG KONG FLU, WHEN THEY CRACKED A RIB FROM COUGHING. THE LUNG DR, GAVE PT A PRESCRIPTION FOR ZITHROMAX WHICH SAVED THEM FROM GOING TO THE HOSP. PT HAD TO GET ANOTHER PRESCRIPTION AND EVEN IT DID NOT GET RID OF THE PNEUMONIA ENTIRELY. IT LEFT PT WITH A CRACKLING SOUND IN THEIR LUNGS WHICH THEY STILL HAVE AT THE PRESENT TIME. PT DEVELOPED A PULSATING HEADACHE IN THE BACK OF THE LEFT SIDE OF THEIR HEAD DAY AND NIGHT FOR 6 MONTHS. THAT WAS THE ONLY TIME PT WISHED THEY COULD DIE. PT HAS AN OMRON BLOOD PRESSURE MACHINE WHICH SHOWED THEIR PULSE RATE GOING TO 116 TO 120. THE HIGHER IT WENT THE MORE PAIN PT HAD. A DR GAVE SOME ANTI-DEPRESSANT PILLS BUT WHEN PT LOOKED IN THE PILL BOOK IT SAID DO NOT TAKE IF YOU HAVE A HIGH PULSE RATE AND PT DID NOT TAKE THEM. PT COULD NOT TAKE PAIN PILLS AND ADVIL DID NOT HELP. PT READ WHERE THE CANADIAN GOVERNMENT OKAYED FEVERFEW FOR MIGRAINE HEADACHES AND PT STATED TAKING THE FEVERFEW. IT IS A SLOW ACTING REMEDY AND IT TOOK 22 DAYS BEFORE THE HEADACHES WENT AWAY. TWO OTHER HOSPS USE PASTE (EIEFIX) WHICH ONLY TAKES 20 MINUTES TO PROCESS FOR SLEEP APNEA TESTS WITH NO SIDE EFFECTS. A YEAR LATER PT WAS ADMITTED TO HOSP WITH PNEUMONIA AGAIN. THEY WERE GIVEN THE SAME ANTIBIOTIC USING TWO PRESCRIPTIONS. SINCE THEY FOUND THREE SMALL CLOTS ON PT'S RIGHT UPPER LUNG PT WAS PUT ON COUMADIN WHICH THEY WERE ALLERGIC TO. AFTER TWO MONTHS ON COUMADIN PT HAD SUCH A PAIN IN LEFT LUNG THAT THEY FAINTED AND WERE TAKEN TO HOSP. THEY HAD NO ANSWER FOR THE FAINTING. PT STOPPED THE COUMADIN AND IS ON GINKGO WHICH WORKS WITHOUT SIDE EFFECTS. THE RESULTS AT THE HOSP ARE AS FOLLOWS: THE THORACIC AORTA IS CALCIFIED AND TORTUOUS. HEART SLIGHTLY ENLARGED. SEVERAL SMALL CALCIFIED NODULES ARE SEEN AT THE RIGHT LUNG BASE THOUGHT TO BE CALCIFIED GRANDULOMAS. BULLOUS DISEASE IS ALSO IN THE LEFT MID LUNG FIELD. EMPHYSEMATOUS (COPD) OBSTRUCTIVE PULMONARY LUNG DISEASE. PRIOR TO SLEEP APNEA TEST PT WAS IN GOOD HEALTH FOR THEIR AGE. PT CLEANED THEIR GUTTERS ON THEIR TWO-STORY HOUSE, ROTOTILLED GARDEN AND MOWED LAWN. PT CANNOT DO ANY OF THESE NOW. PT HAS NEVER HAD HIGH CHOLESTEROL OR HIGH TRIGLYCERIDES. BLOOD TESTS DID NOT HAVE HIGHS AND LOWS, NEVER HAD AN ENLARGED HEART, NEVER HAD HEADACHES MORE THAN ONCE OR TWICE A YEAR. PT WILL NOW HAVE TO LIVE WITH THE CONSEQUENCES OF PNEUMONIA SUCH AS A CHRONIC COUGH, SHORTNESS OF BREATH, CRACKLING SOUND IN LUNGS, CLOTS IN UPPER RIGHT LUNG AND CALCIFICATION IN BOTH LUNGS. PT HAS NEVER HAD PNEUMONIA EXCEPT WHEN THEY WERE TWO YEARS OLD.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 CALDIUM GLUE AND ETHER GYB * * *

Patients

Seq Age Sex Outcome Treatment
1 * Life Threatening| S