MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-03-17 for THERATRON T80 G10 manufactured by Theratronics International Ltd.
[50531]
The four steel roll pins used to secure the tube shaft to the gentry drive gear were broken.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 9610077-1997-00002 |
MDR Report Key | 82731 |
Report Source | 07 |
Date Received | 1997-03-17 |
Date of Report | 1997-03-17 |
Date of Event | 1997-02-18 |
Date Mfgr Received | 1997-02-20 |
Device Manufacturer Date | 1972-12-01 |
Date Added to Maude | 1997-04-11 |
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 | THERATRON |
Generic Name | COBALT TELETHERAPY DEVICE |
Product Code | IWD |
Date Received | 1997-03-17 |
Model Number | T80 |
Catalog Number | G10 |
Lot Number | NA |
ID Number | NA |
Operator | HEALTH PROFESSIONAL |
Device Availability | Y |
Device Age | * |
Device Eval'ed by Mfgr | N |
Implant Flag | N |
Date Removed | A |
Device Sequence No | 1 |
Device Event Key | 82109 |
Manufacturer | THERATRONICS INTERNATIONAL LTD |
Manufacturer Address | 413 MARCH RD. PO BOX 13140 KANATA, ONTARIO CA K2K 2B7 |
Baseline Brand Name | THERATRON |
Baseline Generic Name | COBALT TELETHERAPY DEVICE |
Baseline Model No | T80 |
Baseline Catalog No | G10 |
Baseline ID | * |
Baseline Device Family | THERATRON |
Baseline Shelf Life [Months] | NA |
Baseline PMA Flag | N |
Baseline 510K PMN | N |
Baseline Preamendment | Y |
Baseline Transitional | N |
510k Exempt | N |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Other | 1997-03-17 |