FDA Adverse Event
Injury
Summary report: N
POLIGRIP
MDR report key: 1649717
·
Received March 30, 2010
Report
- Report Number
- MW5015353
- Event Type
- Injury
- Date Received
- March 30, 2010
- Date of Event
- January 15, 2010
- Report Date
- March 22, 2010
- Manufacturer
- GLAXOSMITHKLINE
- Product Code
- KOQ
- Adverse Event
- Yes
- Report Source
- Voluntary report
- Reporter Location
- FL, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
I USED FIXODENT AND POLIGRIP FROM (B) (6) 2007 UNTIL (B) (6) 2010. I BEGAN EXPERIENCING NUMBNESS AND TINGLING IN MY EXTREMITIES. I RECEIVED MY BLOOD WORK RESULTS ON (B) (6) 2010 AND FOUND OUT MY ZINC LEVEL WAS 218, COPPER WAS NORMAL AT 96. MY DOCTOR WANTS TO FOLLOW UP WITH BLOOD TEST AND NEUROPATHY TREATMENT. DOSE OR AMOUNT: DENTURE CREAM, FREQUENCY: ONCE DAILY, ROUTE: ORAL. DATES OF USE: (B) (6) 2007 - (B) (6) 2010. DIAGNOSIS OR REASON FOR USE: DENTURE ADHESIVE CREAM. EVENT ABATED AFTER USE STOPPED: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | POLIGRIP | NONE | KOQ | GLAXOSMITHKLINE | UNK | ||
| 2 | FIXODENT | NONE | KOL | PROCTER & GAMBLE |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Other| S |