MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-05-08 for RELYX TEMP E 35014 manufactured by 3m Espe Ag.
[446031]
A patienty had a swollen face after a temporary restoration was seated using a 3m espe's zinc oxide eugenol cement relyx temp e. Reportedly, the patient stayed in hospital for 3 days and was treated with cortisone. The temporary restoration is said to be made of protemp 3 garrant, manufactured by 3m espe. After the reaction occurred, the temporary was removed and re-inserted using toothpaste. No further reaction occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611385-2006-00004 |
| MDR Report Key | 712458 |
| Report Source | 05 |
| Date Received | 2006-05-08 |
| Date of Report | 2006-04-13 |
| Date of Event | 2006-04-01 |
| Date Mfgr Received | 2006-04-13 |
| Date Added to Maude | 2006-05-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DR ANDREAS PETERMANN |
| Manufacturer Street | ESPE PLATZ |
| Manufacturer City | SEEFELD 82229 |
| Manufacturer Country | GM |
| Manufacturer Postal | 82229 |
| Manufacturer Phone | 1527001395 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RELYX TEMP E |
| Generic Name | DENTAL ZINC OXIDE EUGENOL CEMENT |
| Product Code | EMB |
| Date Received | 2006-05-08 |
| Model Number | NA |
| Catalog Number | 35014 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 701514 |
| Manufacturer | 3M ESPE AG |
| Manufacturer Address | * SEEFELD, BAVARIA GM 82229 |
| Baseline Brand Name | RELYX TEMP E |
| Baseline Generic Name | DENTAL ZINC OXIDE EUGENOL CEMENT |
| Baseline Model No | NA |
| Baseline Catalog No | 35014 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-05-08 |