MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 1997-05-26 for THERATRON T780 G22 manufactured by Theratronics Intl., Ltd..
[63925]
The cobalt 60 source remained in the "on" position at the end of a pt treatment. The treatment was for a scheduled 1. 85 minutes at 115 centigrays. It was estimated that the pt received an additional 60 centigrays which can normally be compensated for in subsequent treatments.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1997-00004 |
| MDR Report Key | 97028 |
| Report Source | 01,05,06,07 |
| Date Received | 1997-05-26 |
| Date of Report | 1997-05-26 |
| Date of Event | 1997-04-28 |
| Date Mfgr Received | 1997-04-28 |
| Device Manufacturer Date | 1990-04-01 |
| Date Added to Maude | 1997-06-11 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THERATRON |
| Generic Name | COBALT TELETHERAPY DEVICE |
| Product Code | IWD |
| Date Received | 1997-05-26 |
| Model Number | T780 |
| Catalog Number | G22 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| 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 | 95792 |
| Manufacturer | THERATRONICS INTL., LTD. |
| Manufacturer Address | 413 MARCH RD. P O BOX 13000 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. Required No Informationntervention | 1997-05-26 |