WEBCOL

Additional Manufacturer Narrative

AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

Description of Event or Problem

ACCORDING TO THE PATIENT, SHE HAS A CONDITION OF BEING CHRONICALLY ILL. SHE WAS EXPERIENCING VOMITING FOR SEVERAL HOURS AND DIARRHEA FOR SEVERAL DAYS. SHE WAS IN AND OUT OF CONSCIOUSNESS AND COULDN'T HOLD FOOD OR WATER FOR SEVERAL DAYS. SHE CHECKED HER BLOOD PRESSURE AND NOTICED IT HAD DROPPED DANGEROUSLY LOW (84/45, 90/48, AND 60/42). CURRENTLY, SHE IS ON MEDICATION TO STABILIZE HER BLOOD PRESSURE. THE PATIENT ALSO SHOWED SYMPTOMS OF THROAT SWELLING. SHE VISITED A HEMATOLOGIST AND HER BLOOD WORK SHOWED DANGEROUSLY LOW LEVELS OF IRON (6 G/L). THE PATIENT REALIZED SHE USES CARDINAL HEALTH ALCOHOL SKIN PREP WIPES (OVER 10 TIMES A DAY) TO REGULARLY WIPE HER HANDS AND THE CENTRAL LINE ON HER MEDICAL DEVICE. THIS IS THE PROCEDURE INSTRUCTED TO HER BY MEDICAL PROFESSIONALS. SHE AT FIRST BELIEVED SHE HAD FOOD POISONING BUT THEN THOUGHT OF CALLING CARDINAL HEALTH. CARDINAL HEALTH CONFIRMED A RECENT RECALL FOR THE PADS BECAUSE OF A DISCOVERY OF TWO RESISTANT STRAINS OF BACTERIA FOUND ON SEVERAL BATCHES. SHE FURTHER STATED THAT SHE IS STILL EXPERIENCING NAUSEA, FATIGUE, NOSE BLEEDS, AND A SKIN INFECTION ON HER NOSE AND LIPS.