MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-12-23 for THERATRON T780 G22 manufactured by Theratronics International Limited.
[33449]
When the "treat" button is pressed the timer starts incrementing and the source remains in the fully shielded position. The control console indicators and radiation monitor accurately reflected the source beam position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1996-00004 |
| MDR Report Key | 61513 |
| Report Source | 07 |
| Date Received | 1996-12-23 |
| Date of Report | 1996-12-10 |
| Date of Event | 1996-12-10 |
| Date Mfgr Received | 1996-12-10 |
| Device Manufacturer Date | 1973-11-01 |
| Date Added to Maude | 1997-01-14 |
| 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 | PHYSICIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | NO |
| 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 | 1996-12-23 |
| Model Number | T780 |
| Catalog Number | G22 |
| Lot Number | NA |
| ID Number | NA |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 61864 |
| Manufacturer | THERATRONICS INTERNATIONAL LIMITED |
| Manufacturer Address | PO BOX 13140 413 MARCH RD KANATA, ONTARIO CA K2K 2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T780 |
| Baseline Catalog No | G22 |
| Baseline ID | * |
| Baseline Device Family | THERATRON |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-12-23 |