FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL

Report

Report Number: 1530449-2010-00070
Event Type: Other
Date Received: May 7, 2010
Date of Event: January 1, 2008
Report Date: April 28, 2010
Manufacturer: PROCTER & GAMBLE MANUFACTURING CO.
Product Code: KOO
PMA / PMN Number: (US) OTC DEV
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: UNKNOWN

Narratives

Additional Manufacturer Narrative · 1

LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY REPORTER THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PMA/510(K)#K945200.

Description of Event or Problem · 1

NEUROPATHY [NEUROPATHY PERIPHERAL]. NUMBNESS IN LEGS AND FEET [HYPOAESTHESIA]. BLOOD ZINC WAS HIGH [BLOOD ZINC INCREASED]. KEPT FALLING [FALL]. CASE DESCRIPTION: A REPRESENTATIVE OF A REGULATORY AUTHORITY REPORTED THAT A CONSUMER, AGE AND GENDER NOT SPECIFIED, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM 1 APPLIC, 3/DAY AS THEIR DENTURE ADHESIVE OF CHOICE ON THEIR BOTTOM DENTURES, CONCURRENTLY WITH POLIGRIP 1 APPLIC, 1/DAY AS THEIR DENTURE ADHESIVE OF CHOICE ON THEIR TOP DENTURES BEGINNING IN 1996 UNTIL PRESENT ((B)(6) 2010), AND REPORTED THE FOLLOWING: BEGAN TO EXPERIENCE NUMBNESS IN LEGS AND FEET; COULD NOT FEEL THE CAR PEDAL - STOPPED DRIVING IN 2008; KEPT FALLING - BEGAN TO USE A WALKER; DIAGNOSED WITH NEUROPATHY IN 2008; BLOOD ZINC WAS HIGH - CONFIRMED BY BLOOD TEST. TREATMENT: HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. NO FURTHER INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33 %, CELL	DENTURE ADHESIVE	KOO	PROCTER & GAMBLE MANUFACTURING CO.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability