MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2008-10-17 for ORTHORALIX SD II PANORAMIC X-RAY SYSTEM SD 2 N/A manufactured by Gendex Dental Systems.
[16832941]
The overhead of the panoramic x-ray unit did not stop when lowered, and landed on the patient's shoulders.
Patient Sequence No: 1, Text Type: D, B5
[16973211]
The patient did not need medical attention with this incident. The overhead of the panoramic x-ray unit did not stop when lowered. Unit will be returned to manufacturer for further evaluation. Follow-up report will be submitted once evaluation is completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004115000-2008-00019 |
| MDR Report Key | 1199183 |
| Report Source | 06 |
| Date Received | 2008-10-17 |
| Date of Report | 2008-09-18 |
| Date of Event | 2008-09-18 |
| Date Mfgr Received | 2008-09-18 |
| Device Manufacturer Date | 1998-09-01 |
| Date Added to Maude | 2009-11-02 |
| 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 | MRS. MARI LAMBERT |
| Manufacturer Street | 901 W. OAKTON STREET |
| Manufacturer City | DES PLAINES IL 600181884 |
| Manufacturer Country | US |
| Manufacturer Postal | 600181884 |
| Manufacturer Phone | 8473603958 |
| Manufacturer G1 | GENDEX DENTAL SYSTEMS |
| Manufacturer Street | 901 WEST OAKTON STREET |
| Manufacturer City | DES PLAINES IL 60018188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60018 1884 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ORTHORALIX SD II PANORAMIC X-RAY SYSTEM |
| Generic Name | DENTAL X-RAY EQUIPMENT |
| Product Code | EAP |
| Date Received | 2008-10-17 |
| Model Number | SD 2 |
| Catalog Number | N/A |
| 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 | 901 WEST OAKTON STREET DES PLAINES IL 60018188 US 60018 1884 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-10-17 |