MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-07-10 for 765DC INTRAORAL X-RAY 110-0155G1 A0765DC75 manufactured by Gendex Dental Systems.
[881033]
The assistant went to position the x-ray unit over the patient to take an x-ray, and the unit fell off the wall, hitting the patient's waist and knees.
Patient Sequence No: 1, Text Type: D, B5
[8076863]
Patient was shook up and stated her vision was blurry. The unit fell off the wall leaving just a wire sticking out of the wall. The bottom of the back casting was cracked away leaving the bottom lag screw in place and the top lag screw was out. The doctor is holding on to the 765dc i/o unit pending his request for a new unit.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00012 |
| MDR Report Key | 1075009 |
| Report Source | 05,06 |
| Date Received | 2008-07-10 |
| Date of Report | 2008-06-11 |
| Date of Event | 2008-06-11 |
| Date Mfgr Received | 2008-06-11 |
| Device Manufacturer Date | 2005-04-14 |
| Date Added to Maude | 2008-09-18 |
| 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 W. OAKTON |
| 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 | 765DC INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-07-10 |
| Model Number | 110-0155G1 |
| Catalog Number | A0765DC75 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1181423 |
| Manufacturer | GENDEX DENTAL SYSTEMS |
| Manufacturer Address | 901 W. OAKTON DES PLAINES IL 60018 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-10 |