MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2000-07-17 for DENTO-SURG 90 FFP EDS 193 manufactured by Ellman International Inc..
[17245812]
Bone death with necrosis of epithelial attachment re: tooth #11.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2428235-2000-00004 |
| MDR Report Key | 285906 |
| Report Source | 00 |
| Date Received | 2000-07-17 |
| Date of Report | 2000-07-17 |
| Date of Event | 1998-11-16 |
| Date Mfgr Received | 2000-07-17 |
| Date Added to Maude | 2000-07-19 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JOANN DEMEO |
| Manufacturer Street | 1135 RAILROAD AVE |
| Manufacturer City | HEWLETT NY 11557 |
| Manufacturer Country | US |
| Manufacturer Postal | 11557 |
| Manufacturer Phone | 5165691482 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DENTO-SURG 90 FFP |
| Generic Name | RADIOSURGERY GENERATOR |
| Product Code | EKZ |
| Date Received | 2000-07-17 |
| Model Number | 90 FFP |
| Catalog Number | EDS 193 |
| Lot Number | NA |
| ID Number | NA |
| Operator | UNKNOWN |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 276671 |
| Manufacturer | ELLMAN INTERNATIONAL INC. |
| Manufacturer Address | 1135 RAILROAD AVE HEWLETT NY 11557 US |
| Baseline Brand Name | DENTO-SURG 90 FFP |
| Baseline Generic Name | RADIOSURGERY GENERATOR |
| Baseline Model No | 90 FFP |
| Baseline Catalog No | EDS 193 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-07-17 |