MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-31 for KODAK SENSOR 6100 manufactured by Carestream Health, Inc..
[66144927]
Patient Sequence No: 1, Text Type: N, H10
[66144928]
Upon taking bite-wing x-rays on a patient, the x-ray sensor would take multiple images with one touch of the button. There was no additional radiation exposure. The device dispensed the normal amount of radiation for one image.
Patient Sequence No: 1, Text Type: D, B5
[67880452]
Patient Sequence No: 1, Text Type: N, H10
[67880453]
Upon taking bite-wing x-rays on a patient, the x-ray sensor would take multiple images with one touch of the button. There was no additional radiation exposure. The device dispensed the normal amount of radiation for one image.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6289291 |
| MDR Report Key | 6289291 |
| Date Received | 2017-01-31 |
| Date of Report | 2017-01-06 |
| Date of Event | 2016-12-14 |
| Report Date | 2017-01-06 |
| Date Reported to FDA | 2017-01-06 |
| Date Reported to Mfgr | 2017-01-06 |
| Date Added to Maude | 2017-01-31 |
| 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 |
| 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 SENSOR 6100 |
| Generic Name | SYSTEM,X-RAY,EXTRAORAL SOURCE,DIGITAL |
| Product Code | MUH |
| Date Received | 2017-01-31 |
| Model Number | 6100 |
| ID Number | C1841 |
| Device Availability | * |
| Device Age | 7 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARESTREAM HEALTH, INC. |
| Manufacturer Address | 1049 WEST RIDGE ROAD ROCHESTER NY 14615 US 14615 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-01-31 |