FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59
Report
- Report Number
- 1530449-2010-00081
- Event Type
- Other
- Date Received
- May 26, 2010
- Report Date
- May 6, 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
LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER, THEREFORE, UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PMA/510(K) # K945200.
PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. NEUROPATHY [NEUROPATHY PERIPHERAL]. EXCESS ZINC [BLOOD ZINC INCREASED]. COPPER DEPLETION [BLOOD COPPER DECREASED]. PROFOUND AND PERMANENT INJURIES; SEVERE AND PERMANENT PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN, WITH A LAST KNOWN USE IN 2009, AND REPORTED THE FOLLOWING: PROFOUND AND PERMANENT NEUROLOGICAL INJURIES, NEUROPATHY, EXCESS ZINC, COPPER DEPLETION, PROFOUND AND PERMANENT INJURIES WHICH HAVE LEFT HER UNABLE TO PERFORM HER NORMAL, CUSTOMARY AND DAILY ACTIVITIES. SHE HAS RECEIVED AND WILL CONTINUE TO RECEIVE UNSPECIFIED MEDICAL CARE AND TREATMENT. THE CASE OUTCOME WAS NOT RECOVERED/NOT RESOLVED. PAST MEDICAL HISTORY INCLUDED: MEDICAL HISTORY - DENTURE WEARER FOR APPROXIMATELY OVER 10 YEARS. NO FURTHER INFORMATION 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 | 58 YR | Disability |