MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-04-03 for GX765DC INTRAORAL X-RAY 110-0155G1 A0765DC75 manufactured by Gendex Dental Systems.
[811492]
X-ray unit fell off the wall during use.
Patient Sequence No: 1, Text Type: D, B5
[8049453]
The wall plate cracked away from the wall, leaving the lag screws in place. The upper and lower pieces of the oval casting were still on the wall with the lag screws. The unit was caught and no one was injured. Remainder of the unit was okay. Sending out a new wall mount with bearings.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00004 |
| MDR Report Key | 1026511 |
| Report Source | 06 |
| Date Received | 2008-04-03 |
| Date of Report | 2008-03-04 |
| Date of Event | 2008-03-03 |
| Date Mfgr Received | 2008-03-04 |
| Device Manufacturer Date | 2001-04-03 |
| Date Added to Maude | 2008-07-16 |
| 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 ST. |
| Manufacturer City | DES PLAINES IL 60018 |
| Manufacturer Country | US |
| Manufacturer Postal | 60018 |
| Manufacturer Phone | 8473643958 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GX765DC INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-04-03 |
| Model Number | 110-0155G1 |
| Catalog Number | A0765DC75 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1023514 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-04-03 |