MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2010-06-30 for DILON 6800 00-00014 manufactured by Dilon Technologies, Inc..
[1371832]
The technologist was preparing to perform an axilla image on a patient supine on a gurney. While positioning the detector near the patient's axilla, the detector separated from its mount, falling to the gurney. Neither the patient nor the technologist was injured.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1125612-2010-00001 |
| MDR Report Key | 1756766 |
| Report Source | 05,06 |
| Date Received | 2010-06-30 |
| Date of Report | 2010-06-25 |
| Date of Event | 2010-05-28 |
| Date Mfgr Received | 2010-05-28 |
| Device Manufacturer Date | 2007-12-01 |
| Date Added to Maude | 2011-01-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | LEE FAIRCHILD |
| Manufacturer Street | 12050 JEFFERSON AVE SUITE 340 |
| Manufacturer City | NEWPORT NEWS VA 23606 |
| Manufacturer Country | US |
| Manufacturer Postal | 23606 |
| Manufacturer Phone | 7572694910 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DILON 6800 |
| Generic Name | CAMERA, SCINTILLATION (GAMMA) |
| Product Code | IYX |
| Date Received | 2010-06-30 |
| Model Number | DILON 6800 |
| Catalog Number | 00-00014 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DILON TECHNOLOGIES, INC. |
| Manufacturer Address | NEWPORT NEWS VA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-30 |