FDA Adverse Event
Injury
Summary report: N
EFFERDENT PLUS
MDR report key: 144348
·
Received January 14, 1998
Report
- Report Number
- 2623619-1997-00001
- Event Type
- Injury
- Date Received
- January 14, 1998
- Date of Event
- December 3, 1997
- Report Date
- December 15, 1997
- Manufacturer
- WARNER LAMBERT CO.
- Product Code
- BSS
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHARMACIST
Narratives
Description of Event or Problem · 1
AN 83 YR OLD FEMALE WITH A HISTORY OF DIABETES MELLITUS, HYPERTENSION, BLINDNESS AND HYPOTHYROIDISM, INGESTED 6 EFFERDENT PLUS TABS ON 12/3/97. SHE WAS TAKEN TO THE HOSP WHERE SHE WAS TREATED WITH ACTIVATED CHARCOAL AND GASTRIC LAVAGE. SHE WAS HEMODYNAMICALLY STABLE, BUT AS A PRECAUTION WAS CARDIAC MONITORED, WITH NO ABNORMALITIES OBSERVED. SERUM CHEMISTRY SHOWED AN INCREASED BUN=25MG/DL AND AN INCREASED CREATININE = 1.2MG/DL. IT WAS NOT DETERMINED IF LAB ABNORMALITIES WERE DUE TO THE INGESTION. PT WAS ADMITTED FOR HYDRATION AND OBSERVATION. SHE ALSO EXPERIENCED ABDOMINAL DISCOMFORT, WHICH WAS THOUGHT TO BE DUE TO THE GASTRIC LAVAGE AND WAS GIVEN REGLAN. SHE RECOVERED AND WAS DISCHARGED AFTER APPROXIMATELY 36 HRS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EFFERDENT PLUS | DENTURE CLEANSER | BSS | WARNER LAMBERT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Hospitalization | 2. GLYBURIDE (GLIBENCLAMIDE), ROUTE: ORAL.| 1. CAPTOPRIL (CAPTOPRIL),ROUTE: ORAL.| 3. LEVOTHYROXINE (LEVOTHYROXINE), ROUTE: ORAL. |