FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE
Report
- Report Number
- 1530449-2010-00016
- Event Type
- Other
- Date Received
- April 5, 2010
- Report Date
- February 18, 2010
- Manufacturer
- PROCTER & GAMBLE MANUFACTURIN CO.
- Product Code
- KOO
- PMA / PMN Number
- (US)OTC DEVI
- 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.
EVENT VERBATIM [PREFERRED TERM] (RELATED SYMPTOMS IF ANY SEPARATED BY COMMAS). PROFOUND AND PERMANENT NEUROLOGICAL INJURIES [NERVOUS SYSTEM DISORDER]. NEUROPATHY [NEUROPATHY PERIPHERAL], EXCESS ZINC [BLOOD ZINC INCREASED], COPPER DEPLETION [BLOOD COPPER DECREASED], OTHER PROFOUND AND PERMANENT INJURIES, PHYSICAL INJURIES [INJURY]. CASE DESCRIPTION: AN ATTORNEY REPORTED THAT THEIR CLIENT, A MALE AGE (B)(6), USED FIXODENT DENTURE ADHESIVE, VERSION UNK CREAM AND SUPER POLIGRIP, AS DENTURE ADHESIVE PRODUCTS OF CHOICE, AND REPORTED THE FOLLOWING: NEUROPATHY DIAGNOSED IN 2008; DIAGNOSED WITH EXCESS ZINC AND COPPER DEPLETION; PROFOUND AND PERMANENT NEUROLOGICAL INJURIES; OTHER PROFOUND AND PERMANENT INJURIES; PHYSICAL INJURIES WHICH HAVE LEFT HIM UNABLE TO PERFORM HIS NORMAL, CUSTOMARY AND DAILY ACTIVITIES. HE 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. NO FURTHER INFO WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXODENT DENTURE ADHESIVE, VERSION UNK (CALCIUM ZINC GANTREZ SALT 33% CELLULOSE | DENTURE ADHESIVE | KOO | PROCTER & GAMBLE MANUFACTURIN CO. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Disability |