MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-10-26 for THERATRON T1000 G90 manufactured by Theratronics.
[116921]
A pt rec'd a cut finger while holding onto the treatment table stretcher top when the operator moved the top longitudinally.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610077-1998-00015 |
| MDR Report Key | 194599 |
| Report Source | 05 |
| Date Received | 1998-10-26 |
| Date of Report | 1998-09-22 |
| Date Mfgr Received | 1998-09-16 |
| Device Manufacturer Date | 1998-10-01 |
| Date Added to Maude | 1998-11-03 |
| 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 |
| Reporter Occupation | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| 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 | IWH |
| Date Received | 1998-10-26 |
| Model Number | T1000 |
| Catalog Number | G90 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 189060 |
| Manufacturer | THERATRONICS |
| Manufacturer Address | 413 MARCH RD. P.O. BOX 13140 KANATA, ONTARIO CA K2K 2B7 |
| Baseline Brand Name | THERATRON |
| Baseline Generic Name | COBALT TELETHERAPY DEVICE |
| Baseline Model No | T1000 |
| Baseline Catalog No | G90 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1998-10-26 |