FDA Adverse Event
Injury
Summary report: N
FIXODENT
MDR report key: 1962615
·
Received January 12, 2011
Report
- Report Number
- MW5018995
- Event Type
- Injury
- Date Received
- January 12, 2011
- Date of Event
- January 1, 2006
- Report Date
- January 4, 2011
- Manufacturer
- PROCTOR & GAMBLE
- Product Code
- KOO
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OK, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I USED FIXODENT FOR MY DENTURE BRIDGE FROM APPROX (B)(6) 2006 TO (B)(6) 2010. I STOPPED USING FIXODENT BECAUSE OF NUMBNESS AND TINGLING IN MY UPPER AND LOWER EXTREMITIES. SINCE THEN I AM HAVING LABS AND DIFFERENT TESTS TO OBTAIN A DIAGNOSIS. WHILE WAITING, I AM RECEIVING PHYSICAL THERAPY. FREQUENCY: ONCE DAILY, ROUTE: ORAL. DATES OF USE: (B)(6) 2006 TO (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE BRIDGE. EVENT ABATED AFTER USE: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIXODENT | NONE | KOO | PROCTOR & GAMBLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Other| S |