MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2008-07-10 for GX770 INTRAORAL X-RAY 46-404600G6 A0770JT manufactured by Gendex Dental Systems.
[881035]
The tubehead of the gx770 i/o unit fell off of the yoke and landed on the pt's chest.
Patient Sequence No: 1, Text Type: D, B5
[8067876]
The pt was unharmed from the incident. The tubehead came free from the yoke. A set screw was missing. Conclusions - when a replacement screw is sent and received, the unit will be repaired by the service technician.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00013 |
| MDR Report Key | 1075015 |
| Report Source | 05 |
| Date Received | 2008-07-10 |
| Date of Report | 2008-06-13 |
| Date of Event | 2008-06-04 |
| Date Mfgr Received | 2008-06-13 |
| Device Manufacturer Date | 2006-12-05 |
| Date Added to Maude | 2009-11-17 |
| 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 |
| Reporter Occupation | DENTIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARI LAMBERT, MGR |
| Manufacturer Street | 901 WEST OAKTON |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX770 INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-07-10 |
| Model Number | 46-404600G6 |
| Catalog Number | A0770JT |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-10 |