FDA Adverse Event Injury Summary report: N

POLYGRIP

MDR report key: 1652469 · Received March 31, 2010

Report

Report Number
MW5015440
Event Type
Injury
Date Received
March 31, 2010
Report Date
February 10, 2009
Manufacturer
GLAXOSMITHKLINE, CONSUMER HEALTHCARE LLC
Product Code
KOL
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

THE COMPLAINANT REPORTED AN ADVERSE EVENT INVOLVING POLYGRIP. IN 1998, SHE STARTED USING POLYGRIP. IN 2001, SHE HAD MYELODYSPLASIA AND WAS GIVEN INJECTIONS TO GET HER RED BLOOD CELL COUNT BACK UP. THE INJECTIONS WERE NOT EFFECTIVE. SHE WAS GIVEN BLOOD TRANSFUSIONS AND A BONE MARROW TRANSPLANT. HER DOCTORS THOUGHT SHE HAD AN AUTOIMMUNE DISORDER. HER WHITE CELL COUNT WENT WAY DOWN, AND SHE WAS GIVEN INJECTIONS TO GET IT BACK UP. EVENTUALLY, THE CONDITION RESOLVED ON ITS OWN. IN 2005, SHE DEVELOPED "DROP FOOT" IN HER RIGHT FOOT. IT WENT INTO HER LEFT FOOT AND HANDS. SHE EXPERIENCED WEAKNESS IN HER HANDS AND LOST WEIGHT. SHE SAW A NEUROLOGIST WHO THOUGHT SHE MIGHT HAVE ADL (LOU GEHRIG'S DISEASE). ALL THIS OCCURRED WITHIN A MONTH IN 2005. SHE WAS REFERRED TO ANOTHER NEUROLOGIST IN ANOTHER HOSPITAL. HER BLOOD TEST INDICATED LOW COPPER LEVELS. SHE LEARNED 2 TO 3 WEEKS AGO THAT ZINC IN POLYGRIP LOWERS COPPER LEVELS. A DOCTOR IN (B) (6) PUT HER ON 2 MG COPPER PER DAY. SHE WAS IN A WHEELCHAIR 2005-2006. SHE NOW CAN WALK WITH A CAIN. SHE STILL HAS LIMITED USE OF HER HANDS (THEY ARE CURLED UP). SHE FALLS CONSTANTLY.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 POLYGRIP NONE KOL GLAXOSMITHKLINE, CONSUMER HEALTHCARE LLC

Patients

Seq Age Sex Outcome Treatment
1