FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN (CALCIUM ZINC GANTREZ SALT 33-59
Report
- Report Number
- 1530449-2010-00034
- Event Type
- Other
- Date Received
- April 5, 2010
- Report Date
- February 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
LOT NUMBER OR PRODUCT WAS NOT PROVIDED BY THE REPORTER THEREFORE UNABLE TO PROCEED WITH BATCH RETAIN TESTING OR PRODUCT INVESTIGATION. PMA/510(K)# 945200.
NEUROPATHY (PROVISIONAL DIAGNOSIS) [NEUROPATHY PERIPHERAL]. EXCESS ZINC [HYPERZINCAEMIA]. COPPER DEPLETION [BLOOD COPPER DECREASED]. OTHER INJURIES AND PERMANENT PHYSICAL INJURIES [INJURY]. PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A FEMALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, FORM/VERSION UNKNOWN, AND SUPER POLIGRIP DENTURE ADHESIVE INTERCHANGEABLE FOR SEVERAL YEARS, WITH A LAST KNOWN USE APPROXIMATELY (B)(6) 2009 AND REPORTED THE FOLLOWING: NEUROPATHY (PROVISIONAL DIAGNOSIS) ATTRIBUTED TO EXCESS ZINC AND RESULTING IN COPPER DEPLETION, OTHER UNSPECIFIED INJURIES AND PERMANENT PHYSICAL INJURIES, UNSPECIFIED PERMANENT NEUROLOGICAL INJURIES AND DISABILITIES 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. 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 | 48 YR | Disability |