FDA Adverse Event Other Summary report: N

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

MDR report key: 2844968 · Received November 14, 2012

Report

Report Number: 1530449-2012-00079
Event Type: Other
Date Received: November 14, 2012
Report Date: November 5, 2012
Manufacturer: PROCTER & GAMBLE MANUFACTURING CO.
Product Code: KOO
PMA / PMN Number: K945200
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER; THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION.

Description of Event or Problem · 1

PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. ATTRIBUTED TO EXCESS ZINC [HYPERZINCAEMIA]. RESULTING IN COPPER DEPLETION [COPPER DEFICIENCY]. ZINC POISONING [METAL POISONING]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CURRENTLY (B)(6), FEMALE CLIENT, USED FIXODENT DENTURE ADHESIVE, VERSION UNKNOWN CREAM FOR HER DENTURES BEGINNING IN 1996 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, SEVERE AND PERMANENT PHYSICAL INJURIES ATTRIBUTED TO EXCESS ZINC RESULTING IN COPPER DEPLETION AND ZINC POISONING LEAVING HER UNABLE TO PERFORM NORMAL, CUSTOMARY, AND DAILY ACTIVITIES. HEALTH CARE PROFESSIONAL WAS VISITED. TREATMENT: UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. SHE DISCONTINUED USE OF THE PRODUCT. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER (APPROXIMATELY 16 YEARS AGO). 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%, CELLU	DENTURE ADHESIVE	KOO	PROCTER & GAMBLE MANUFACTURING CO.

Patients

Seq	Age	Sex	Outcome	Treatment
1			Disability