FDA Adverse Event Other Summary report: N

FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59

MDR report key: 1700988 · Received May 26, 2010

Report

Report Number: 1530449-2010-00083
Event Type: Other
Date Received: May 26, 2010
Report Date: May 12, 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

OTC PRODUCT: YES. PMA/510(K) # K945200. LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE RPTR 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]. PROFOUND AND PERMANENT INJURIES [INJURY]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT HIS CLIENT, AN ADULT FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNK AND SUPER POLIGRIP DENTURE ADHESIVE BEGINNING 2001, WHEN SHE BECAME DENTURE DEPENDENT, THROUGH 2009 AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, PROFOUND AND PERMANENT INJURIES THAT HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES, AND EXCESS ZINC AND COPPER DEPLETION BOTH BEGINNING 2009. TREATMENT: CONSTANT (UNSPECIFIED) CARE AND ASSISTANCE. THE CASE OUTCOME WAS NOT COVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER SINCE 2001. NO FURTHER INFO WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59	DENTURE ADHESIVE	KOO	PROCTER & GAMBLE MANUFACTURING CO.

Patients

Seq	Age	Sex	Outcome	Treatment
1	44 YR		Disability