MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-07-02 for EXPERT DC INTRAORAL X-RAY 110-0205G1 EXPERTDC75 NA manufactured by Gendex Dental System.
[882087]
The lower mount of the wall plate cracked, and the x-ray unit fell off the wall.
Patient Sequence No: 1, Text Type: D, B5
[7892253]
There was no pt or user injury with this incident. After inspection on site, it was found that the stud the unit was mounted to had cracked in half. The wall plate will be replaced.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00011 |
| MDR Report Key | 1068040 |
| Report Source | 06 |
| Date Received | 2008-07-02 |
| Date of Report | 2008-06-04 |
| Date of Event | 2008-06-04 |
| Date Mfgr Received | 2008-06-04 |
| Device Manufacturer Date | 2008-03-14 |
| Date Added to Maude | 2009-09-25 |
| 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 | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXPERT DC INTRAORAL X-RAY |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-07-02 |
| Model Number | 110-0205G1 |
| Catalog Number | EXPERTDC75 NA |
| 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 SYSTEM |
| Manufacturer Address | 901 WEST OAKTON ST. DES PLAINES IL 60018 US 60018 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-07-02 |