MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 1996-12-06 for THERATRON T7801EC G61B manufactured by Theratronics Intl. Ltd..
[36403]
During treatment the pt pushed his arm on the removable support assembly. The latchkeeper was not securing the support assembly properly and the crank stop pin was too far inside the drilling hole to stop the support from rotating. The pt and the removable support fell to the floor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1996-00002 |
| MDR Report Key | 59715 |
| Report Source | 00,01 |
| Date Received | 1996-12-06 |
| Date of Report | 1996-11-25 |
| Date of Event | 1996-10-30 |
| Date Mfgr Received | 1996-11-18 |
| Device Manufacturer Date | 1996-02-01 |
| Date Added to Maude | 1997-01-03 |
| 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 |
| 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 | 1996-12-06 |
| Model Number | T7801EC |
| Catalog Number | G61B |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 60132 |
| Manufacturer | THERATRONICS INTL. LTD. |
| Manufacturer Address | P.O. BOX 13140 413 MARCH RD KANATA, ONTARIO CA K2K2B7 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-12-06 |