MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-12-25 for KERR * manufactured by Kerr Corp..
[392852]
The co, kerr corp, div of sybron dental specialties produces class ii medical devices and does not conduct any limulus amebocyte lysate tests on any of its products as required by the fda guidelines.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1034289 |
| MDR Report Key | 565189 |
| Date Received | 2004-12-25 |
| Date of Report | 2004-12-25 |
| Date Added to Maude | 2005-01-13 |
| 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 | 3 |
| 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 | KERR |
| Generic Name | DENTAL MATERIALS |
| Product Code | EMN |
| Date Received | 2004-12-25 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 554961 |
| Manufacturer | KERR CORP. |
| Manufacturer Address | * ORANGE CA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-12-25 |