MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 1996-10-25 for ALCYON TYPE II S6100A manufactured by Ge Medical Systems Europe.
[24694]
Pt may as reported through a foreign news report have received excessive radiation exposure when undergoing radiation therapy treatment on a therapy device. One hundred and nine pts were involed from 8/26-8/27/96. This has been attributed to an error in dosimetery b the user of the equipment. There has been no reported malfunction o the device. Several of the pts reportedly have exhibited symptoms of chronic radiation overexposure and 3 pts described as being terminal cancer pts have died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1996-00015 |
| MDR Report Key | 44953 |
| Report Source | 00 |
| Date Received | 1996-10-25 |
| Date of Report | 1996-10-25 |
| Date of Event | 1996-08-26 |
| Date Mfgr Received | 1996-10-23 |
| Date Added to Maude | 1996-10-30 |
| 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 | ALCYON |
| Generic Name | RADIO-THERAPY |
| Product Code | IWD |
| Date Received | 1996-10-25 |
| Model Number | TYPE II |
| Catalog Number | S6100A |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 45857 |
| Manufacturer | GE MEDICAL SYSTEMS EUROPE |
| Manufacturer Address | 283, RUE DE LA MINIERE, BP 34 BUC CEDEX FR 78533 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Other | 1996-10-25 |