MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2015-01-09 for PROVECTA S-PAN A7350 manufactured by Vatech Co, Ltd.
[5421463]
Observed the potential of the utility software driver to present x-ray and place x-ray images in a pc folder that could then be captured by the dentist and matched to a new or wrong pt. Dentist would detect and match the proper image to a pt based their clinical examination and complete clinical assessment before using panoramic x-ray images.
Patient Sequence No: 1, Text Type: D, B5
[12756355]
There were no operator or pt injury associated with this incident, but an observation described by a customer/dentist during routine use of x-ray images. Images cannot be lost because images are back-up by the twain interface. Images can be easily retrieved and assigned to the proper pt by dentist based on their clinical experience and specific knowledge of the pt's dental anatomy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2428225-2014-00004 |
| MDR Report Key | 4412400 |
| Report Source | 06 |
| Date Received | 2015-01-09 |
| Date of Report | 2015-01-09 |
| Date of Event | 2014-12-09 |
| Date Facility Aware | 2014-12-09 |
| Report Date | 2015-01-09 |
| Date Reported to Mfgr | 2014-12-19 |
| Date Mfgr Received | 2014-12-19 |
| Device Manufacturer Date | 2014-07-09 |
| Date Added to Maude | 2015-01-30 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SEAN KIM |
| Manufacturer Street | 23-4, SEOGU-DONG, HWASENG-SI |
| Manufacturer City | GYEONGGI-DO 445-170 |
| Manufacturer Country | KS |
| Manufacturer Postal | 445-170 |
| Manufacturer Phone | 13799585 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROVECTA S-PAN |
| Generic Name | DIGITAL X-RAY IMAGING SYTEM |
| Product Code | MUH |
| Date Received | 2015-01-09 |
| Model Number | A7350 |
| Catalog Number | A7350 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | VATECH CO, LTD |
| Manufacturer Address | GYEONGGI-DO KS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-01-09 |