FDA Adverse Event
Injury
Summary report: N
EXTRA STRENGTH EFFERGRIP
MDR report key: 63906
·
Received January 21, 1997
Report
- Report Number
- 2510770-1997-00001
- Event Type
- Injury
- Date Received
- January 21, 1997
- Date of Event
- January 4, 1997
- Report Date
- January 9, 1997
- Manufacturer
- WARNER LAMBERT CO.
- Product Code
- KOP
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
PHYSICIAN REPORTED THAT ON 1/4/97 A 32-YR-OLD FEMALE PT EXPERINCED AN ANAPHYLACTIC REACTION AFTER USING DENTURE ADHESIVE FOR HER DENTURES. WITHIN TWO MINUTES OF USING THE PRODUCT, THE PT'S LIPS BECAME TINGLY AND HER TONGUE BECAME SWOLLEN THAT SHE COULDN'T PUT BACK IN HER MOUTH. THE PT WAS ADMITTED TO AN ICU WHERE SHE WAS TREATED WITH EPINEPHRINE AND STEROIDS. THE PT HAD HIGH BLOOD PRESSURES AND WAS GIVEN VASOTEC. PT WAS RELEASED 24 HRS LATER AFTER HER BLOOD PRESSURE WAS REDUCED TO NORMAL. THE PT HAS FULLY RECOVERED. THE PT'S PHYSICIAN REPORTS THAT APPROX THREE YRS AGO SHE EXPRIENCED THE SAME EXACT SYMPTOMS AFTER USING THE PRODUCT AND WAS TREATED IN THE ICU WITH EPINEPHRINE AND STEROIDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTRA STRENGTH EFFERGRIP | DENTURE ADHESIVE CREAM | KOP | WARNER LAMBERT CO. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 32 YR | Hospitalization| L |