MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,06,07 report with the FDA on 2002-05-21 for THERATRON T780 G22 manufactured by Mds Nordion.
[246364]
It was reported that the source failed to return to the fully shielded position during the start of pt treatment. The source was returned manually and pt was removed from the room.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8022247-2002-00018 |
| MDR Report Key | 396850 |
| Report Source | 00,05,06,07 |
| Date Received | 2002-05-21 |
| Date of Report | 2002-05-16 |
| Date of Event | 2002-04-19 |
| Date Mfgr Received | 2002-04-19 |
| Device Manufacturer Date | 1994-11-01 |
| Date Added to Maude | 2002-05-31 |
| 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 | MR. ROSS KACHANIWSKY |
| Manufacturer Street | 447 MARCH RD |
| Manufacturer City | KANATA, ONTARIO K2K 1X8 |
| Manufacturer Country | CA |
| Manufacturer Postal | K2K 1X8 |
| Manufacturer Phone | 5923400223 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY DEVICE |
| Product Code | IWD |
| Date Received | 2002-05-21 |
| Model Number | T780 |
| Catalog Number | G22 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 385896 |
| Manufacturer | MDS NORDION |
| Manufacturer Address | 447 MARCH RD KANATA, ONTARIO CA K2K 1X8 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T780 |
| Baseline Catalog No | G22 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-05-21 |