MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2018-02-14 for 765 DC 765DC 0.820.0144 manufactured by Gendex Dental Systems.
[100247230]
The unit has been in use since (b)(6) 2005. The model was discontinued in august 2007. The device will not be returned to the manufacturer for further investigation as the device has already been scrapped by the dental office. No evaluation could be performed on the device. There were no serious injuries reported. The distributor confirmed that the lag bolts pulled out of the wall and was not related to the device itself. This concludes the investigation.
Patient Sequence No: 1, Text Type: N, H10
[100247271]
It was reported that the x-ray fell off the wall and struck a patient. After contacting the dental office, it was reported that the patient is a (b)(6) male who received a scratch. There was no medical intervention reported. No other injries were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2530069-2018-00001 |
| MDR Report Key | 7269261 |
| Report Source | DISTRIBUTOR |
| Date Received | 2018-02-14 |
| Date of Report | 2018-02-13 |
| Date of Event | 2017-12-27 |
| Date Mfgr Received | 2018-01-16 |
| Device Manufacturer Date | 2005-10-05 |
| Date Added to Maude | 2018-02-14 |
| 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 | SERVICE PERSONNEL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. ERIKA MARTIN |
| Manufacturer Street | 2800 CRYSTAL DRIVE |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal | 19440 |
| Manufacturer Phone | 7045877241 |
| Manufacturer G1 | IMAGING SCIENCES INTERNATIONAL/GENDEX/DEXIS |
| Manufacturer Street | 2800 CRYSTAL DRIVE |
| Manufacturer City | HATFIELD PA 19440 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 19440 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 765 DC |
| Generic Name | EXTRAORAL SOURCE X-RAY SYSTEM |
| Product Code | EHD |
| Date Received | 2018-02-14 |
| Model Number | 765DC |
| Catalog Number | 0.820.0144 |
| Operator | DENTIST |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 1910 NORTH PENN ROAD HATFIELD PA 19440 US 19440 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-14 |