MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-10-03 for LINEAR ACCELERATOR TANGENTIAL BREAST BEAM COLLIMATOR 597-014 manufactured by Radiation Products Design.
[18609939]
It has been noted that the block is not long enough to completely block the radiation field when treatment is performed with the collimater wide open, therefore, a small amount of flash radiation hits the pt in an unintended area. This situation only occurs with tangential breast setups.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1003570 |
| MDR Report Key | 16544 |
| Date Received | 1994-10-03 |
| Date of Report | 1994-09-30 |
| Date Added to Maude | 1994-10-04 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LINEAR ACCELERATOR TANGENTIAL BREAST BEAM COLLIMATOR |
| Product Code | IYJ |
| Date Received | 1994-10-03 |
| Model Number | 597-014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 16477 |
| Manufacturer | RADIATION PRODUCTS DESIGN |
| Manufacturer Address | ALBERTVILLE MN 55301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-10-03 |