MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-08-17 for QUIK-FIX BP9881 manufactured by Brimms Laboratory Div Of Brimms, Inc..
[21713703]
The container has no labeling as to its ingredients and it has a very potent odor which incapacitated the user. The user applied it with a fan in use. Even after the glue had dried and they placed their dentures in their mouth the smell of chemicals from the dentures was very potent. The user believes that warning and content labels are inadequate especially considering the risk of allergies to the pt. Rptr is still quite sensitive to chemical odors at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1019683 |
| MDR Report Key | 291173 |
| Date Received | 2000-08-17 |
| Date of Report | 2000-08-17 |
| Date of Event | 2000-01-01 |
| Date Added to Maude | 2000-08-22 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | QUIK-FIX |
| Generic Name | DENTURE REPAIR KIT |
| Product Code | EBO |
| Date Received | 2000-08-17 |
| Model Number | NA |
| Catalog Number | BP9881 |
| Lot Number | 129105 |
| ID Number | BAR CODE 7236305000-8 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 281820 |
| Manufacturer | BRIMMS LABORATORY DIV OF BRIMMS, INC. |
| Manufacturer Address | 425 FILLMORE AVE. TONAWANDA NY 14150 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-08-17 |