FDA Adverse Event
Other
Summary report: N
COREGA LIQUID/GERMANY
MDR report key: 179821
·
Received July 30, 1998
Report
- Report Number
- 9681138-1998-00002
- Event Type
- Other
- Date Received
- July 30, 1998
- Date of Event
- July 1, 1998
- Report Date
- July 24, 1998
- Manufacturer
- BLOCK DRUG COMPANY, INC.
- Product Code
- KOO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PHYSICIAN REPORTED THAT SHE PERFORMED AN "EPICUTAN" TEST ON THE PATIENT USING THE INGREDIENTS IN SUPER COREGA LIQUID; THE PATIENT DID NOT HAVE A REACTION TO ANY OF THE INGREDIENTS. THE PHYSICIAN REPORTED THAT BASED ON THIS RESULT, SHE DID NOT THINK THAT THE PATIENT'S SYMPTOMS WERE RELATED TO USE OF PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COREGA LIQUID/GERMANY | DENTURE ADHESIVE | KOO | BLOCK DRUG COMPANY, INC. | * | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization |