FDA Adverse Event
Malfunction
Summary report: N
FIXODENT
MDR report key: 1842617
·
Received September 20, 2010
Report
- Report Number
- MW5017512
- Event Type
- Malfunction
- Date Received
- September 20, 2010
- Product Code
- KOO
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I USE FIXODENT, HAVE TO MENTION TO DR NOT KNOWING THE REASON, I HAVE DISABILITY IN MY RT HAND, BUT NEVER BEEN EXAMINED FOR THE NUMBNESS BY REPORTING THIS INCIDENT I'M HOPING THAT I CAN GET SOME MEDICAL HELP. I'M NOT SURE THE PRODUCT CAUSE THE PROBLEM, BUT I HAVE NO STRENGTH IN THE HAND. I HAVE CRAMPS, NUMBNESS SOMETIME NO CONTROL WHEN I'M WRITING. I'M HOPING BY VOLUNTARY IN THIS REPORT I'LL GET SOME MORE TESTING. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: ONCE DAILY, ROUTE: ORAL. DATES OF USE: 1975 TO 2010. DIAGNOSIS OR REASON FOR USE: DENTURE. EVENT ABATED AFTER USE: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXODENT | NONE | KOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Other |