MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-05-09 for TOSHIBA CT SYSTEM ACCESSORIES, CARBON FIBER * 9091 manufactured by Cfi Medical Solutions.
[3404477]
Ct technologist was changing the head holder on a ct machine. The head holder is made of carbon fiber. A piece of the carbon fiber splintered off into the palm of the technologist's hand. The splinter was removed, the technologist's hand was cleaned and she went to employee health. No adverse effects from the injury. The head holder did not have any direct patient contact, in this case, but there is a potential for a carbon fiber to splinter off and injure a patient. What was the original intended procedure? The ct head holder was being cleaned at the time and not actively being used. Device #1is this a laboratory device or laboratory test? No.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3110505 |
| MDR Report Key | 3110505 |
| Date Received | 2013-05-09 |
| Date of Report | 2013-05-08 |
| Date of Event | 2013-04-25 |
| Report Date | 2013-05-08 |
| Date Reported to FDA | 2013-05-09 |
| Date Reported to Mfgr | 2013-05-14 |
| Date Added to Maude | 2013-05-14 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TOSHIBA CT SYSTEM ACCESSORIES, CARBON FIBER |
| Generic Name | HOLDER, HEAD, RADIOGRAPHIC |
| Product Code | IWY |
| Date Received | 2013-05-09 |
| Model Number | * |
| Catalog Number | 9091 |
| Lot Number | * |
| ID Number | * |
| Operator | OTHER |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CFI MEDICAL SOLUTIONS |
| Manufacturer Address | 14241 N FENTON RD FENTON MI 48430 US 48430 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-05-09 |