MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07,08 report with the FDA on 1998-03-23 for THERATRON PHOENIX G86 manufactured by Theratronics Intl., Ltd..
[133604]
A report was rec'd that the radioactive source became stuck. The event occurred 4 days after the installation of a replacement cordreel assembly by the foreign svc rep. Different length mounting screws holding the cordreel to its mounting bracket had been mistakenly reversed. This caused the cordreel (attached to the end of the source drawer) to bind and eventually lead to the source becoming stuck.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00006 |
| MDR Report Key | 159656 |
| Report Source | 01,05,07,08 |
| Date Received | 1998-03-23 |
| Date of Report | 1998-03-18 |
| Date of Event | 1997-11-10 |
| Date Mfgr Received | 1998-02-20 |
| Device Manufacturer Date | 1993-10-01 |
| Date Added to Maude | 1998-03-31 |
| 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 |
| 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 | 1998-03-23 |
| Model Number | PHOENIX |
| Catalog Number | G86 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 155498 |
| 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 | PHOENIX |
| Baseline Catalog No | G86 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1998-03-23 |