MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-11 for KODAK 8000 PANORAMIC SYSTEM manufactured by Carestream Dental Llc.
[119873642]
Panorex x-ray ordered by the er physician. The image disappeared from the screen and could not be retrieved. A ct scan of the facial bones had to be ordered.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7864129 |
| MDR Report Key | 7864129 |
| Date Received | 2018-09-11 |
| Date of Report | 2018-08-07 |
| Date of Event | 2017-08-31 |
| Report Date | 2018-08-07 |
| Date Reported to FDA | 2018-08-07 |
| Date Reported to Mfgr | 2018-09-11 |
| Date Added to Maude | 2018-09-11 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | KODAK 8000 PANORAMIC SYSTEM |
| Generic Name | SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITAL |
| Product Code | MUH |
| Date Received | 2018-09-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM DENTAL LLC |
| Manufacturer Address | 1765 THE EXCHANGE ATLANTA GA 30339 US 30339 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-09-11 |