MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-03-31 for INFA-LAB EMERGENCY DENTURE REPAIR KIT NI manufactured by Infa-lab, Inc..
[152989]
Powder and liquid contained in product are completely unlabeled except for warning of flammability. The instructions indicate that the components are to be mixed. Rptr is concerned regarding potential for numerous problems related to lack of labeling.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1018536 |
| MDR Report Key | 271640 |
| Date Received | 2000-03-31 |
| Date of Report | 2000-03-31 |
| Date of Event | 2000-03-31 |
| Date Added to Maude | 2000-04-03 |
| 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 | PHARMACIST |
| 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 | INFA-LAB EMERGENCY DENTURE REPAIR KIT |
| Generic Name | EMERGENCY DENTURE REPAIR KIT |
| Product Code | EBO |
| Date Received | 2000-03-31 |
| Model Number | NI |
| Catalog Number | NI |
| Lot Number | NI |
| ID Number | UPC 7987210010 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 262959 |
| Manufacturer | INFA-LAB, INC. |
| Manufacturer Address | 11 WALL ST. ROCKAWAY NJ 07866 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-31 |