MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-21 for TEMP BOND CEMENT manufactured by Kerr Mfg..
[9582]
Anaphylactic reaction to eugenol in product.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000446 |
| MDR Report Key | 11009 |
| Date Received | 1994-01-21 |
| Date of Report | 1994-01-09 |
| Date of Event | 1993-12-30 |
| Date Added to Maude | 1994-01-24 |
| 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 |
| 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 | TEMP BOND CEMENT |
| Generic Name | DENTAL CEMENT |
| Product Code | EMB |
| Date Received | 1994-01-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 11009 |
| Manufacturer | KERR MFG. |
| Manufacturer Address | ROMULUS MI 48174 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening | 1994-01-21 |