MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,07,08 report with the FDA on 2000-05-04 for THERATRON PHOENIX G86 manufactured by Mds Nordion.
[180517]
A report was received that the long frame accessory tray fell out of the holder. It occurred during a pt treatment. The tray did not hit the pt. No injury to the pt was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2000-00002 |
| MDR Report Key | 276903 |
| Report Source | 00,01,07,08 |
| Date Received | 2000-05-04 |
| Date of Event | 2000-04-04 |
| Date Mfgr Received | 2000-04-13 |
| Device Manufacturer Date | 1998-04-01 |
| Date Added to Maude | 2000-05-11 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | E. MARTELL |
| Manufacturer Street | 447 MARCH RD. |
| Manufacturer City | KANATA, ONTARIO K2K 1X8 |
| Manufacturer Country | * |
| Manufacturer Postal | K2K 1X8 |
| Manufacturer Phone | 5922790 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY DEVICE |
| Product Code | IWD |
| Date Received | 2000-05-04 |
| Model Number | PHOENIX |
| Catalog Number | G86 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 268027 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH RD. KANATA, ONTARIO * K2K 1X8 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | PHOENIX |
| Baseline Catalog No | G86 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-05-04 |