MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-12 for THERATRON COBALT 60 780 manufactured by Theratronics Intl. Ltd..
[20760876]
A new couch was installed in 3/90. In 10/93, on inspection, the ball-screw mechanism was found to be very badly worn, indicating substandard materials in the mfg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1000390 |
| MDR Report Key | 10944 |
| Date Received | 1994-01-12 |
| Date Added to Maude | 1994-01-14 |
| 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 |
| Reporter Occupation | PHYSICIST |
| 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 | THERATRON COBALT 60 |
| Product Code | IWD |
| Date Received | 1994-01-12 |
| Model Number | 780 |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 10944 |
| Manufacturer | THERATRONICS INTL. LTD. |
| Manufacturer Address | ONTARIO CA K2K2B7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-12 |