FDA Adverse Event
Other
Summary report: N
EFFERDENT
MDR report key: 608454
·
Received May 27, 2005
Report
- Report Number
- 2246407-2005-00006
- Event Type
- Other
- Date Received
- May 27, 2005
- Report Date
- May 23, 2005
- Manufacturer
- PFIZER INC.
- Product Code
- KOO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
AN EMPLOYEE AT AN ASSISTED LIVING FACILITY REPORTS THAT A CONSUMER (AGE UNKNOWN) ACCIDENTALLY INGESTED UP TO 15 TABLETS OF EFFERDENT (FORMULATION UNSPECIFIED) (SODIUM PERBORATE MONOHYDRATE, POTASSIUM MONOPERSULFATE) ONCE (DATE UNSPECIFIED). AFTER PRODUCT INGESTION, THEIR MOUTH WAS BLUE AND THEY HAD A STOMACH ACHE. THE STOMACH ACHE WAS TREATED WITH TWO TEASPOONFULS OF PEPTO BISMOL. THE EVENT RESOLVED ON AN UNSPECIFIED DATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EFFERDENT | DENTURE PRODUCT | KOO | PFIZER INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |