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 1997-08-22 for THERATRON T80 G10 manufactured by Theratronics Intl., Ltd..
[17520757]
It was reported that the cobalt 60 source became exposed when the teletherapy unit electrical power was switched on. The unwanted source exposure occurred while the treatment room door was open and the treatment unit's timer was in the "off" position.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1997-00007 |
| MDR Report Key | 115842 |
| Report Source | 01,05,06,07 |
| Date Received | 1997-08-22 |
| Date of Report | 1997-08-13 |
| Date of Event | 1997-07-14 |
| Date Mfgr Received | 1997-07-17 |
| Device Manufacturer Date | 1968-11-01 |
| Date Added to Maude | 1997-08-29 |
| 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 |
| 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 | 1997-08-22 |
| Model Number | T80 |
| Catalog Number | G10 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 113673 |
| Manufacturer | THERATRONICS INTL., LTD. |
| Manufacturer Address | 413 MARCH RD PO BOX 13140 KANATA, ONTARIO CA K2K 2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T80 |
| Baseline Catalog No | G10 |
| 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 | 1997-08-22 |