FDA Adverse Event
Death
Summary report: N
FIXODENT
MDR report key: 1399503
·
Received June 4, 2009
Report
- Report Number
- MW5011337
- Event Type
- Death
- Date Received
- June 4, 2009
- Report Date
- January 28, 2009
- Manufacturer
- PROCTER & GAMBLE
- Product Code
- KOL
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
I HAVE USED FIXODENT, POLIGRIP AND SUPER POLIGRIP SINCE 1978, AND STILL USE IT SOME, BUT NOT EVERY DAY. I HAVE EXPERIENCED NUMBNESS, TINGLING IN LEG, FEET, HANDS AND HAVEN'T HAD BLOOD TEST FOR THE COPPER AND ZINC YET, BUT PLAN TO THE COMING WEEK. DOSE: DENTURE CREAM. FREQUENCY: 1 OR 2 TIMES/DAY. ROUTE: ORAL. DATES OF USE: 1978 - 2009. DIAGNOSIS: DENTURE CREAM. I HAD A BLOOD "TREENELET" IN 2007.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXODENT | NONE | KOL | PROCTER & GAMBLE | UNK | ||
| 2 | POLIGRIP | NONE | KOL | UNK | |||
| 3 | SUPER POLI-GRIP | NONE | KOL | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Death| H |