MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,05,07 report with the FDA on 1998-05-22 for THERATRON T780 G22 manufactured by Theratronics Intl., Ltd..
[95850]
It was reported the collimator field was out of specification by more than 3 millimeters. Therefore the field light which is used to set up patients, does not coinside exactly with the radiation field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00008 |
| MDR Report Key | 170613 |
| Report Source | 00,05,07 |
| Date Received | 1998-05-22 |
| Date of Report | 1998-05-22 |
| Date of Event | 1998-04-01 |
| Date Mfgr Received | 1998-04-22 |
| Device Manufacturer Date | 1981-03-01 |
| Date Added to Maude | 1998-06-03 |
| 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 | 3 |
| Single Use | 3 |
| Remedial Action | RP |
| 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 | 1998-05-22 |
| 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 | 165954 |
| Manufacturer | THERATRONICS INTL., LTD. |
| Manufacturer Address | 413 MARCH RD. P.O. BOX 13140 KANATA, ONTARIO * 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 | 1998-05-22 |