D
Patient 1
THE OVERHEAD OF THE PANORAMIC X-RAY UNIT DID NOT STOP WHEN LOWERED, AND LANDED ON THE PATIENT'S SHOULDERS.
MAUDE MDR 1199183
- MDR report key
- 1199183
- Report number
- 3004115000-2008-00019
- Event key
- 0
- Event type
- 3
- Date of event
- 2008-09-18
- Date received
- 2008-10-17
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 116
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Contact
- MRS. MARI LAMBERT
- Address
- 901 W. OAKTON STREET DES PLAINES IL 60018 US
- Phone
- 847-847-8473
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | ORTHORALIX SD II PANORAMIC X-RAY SYSTEM | DENTAL X-RAY EQUIPMENT | GENDEX DENTAL SYSTEMS | EAP | SD 2 | N/A | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2008-10-17 | 0 |
Event Narratives#
N
Patient 1
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.