MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-09-26 for FUJIFILM IMAGING PLATE * manufactured by Fujifilm Medical System U.s.a., Inc..
[16852082]
A foreign body (wire) was identified on patient's forearm x-ray. Film reviewed and confirmed by a radiologist. Approximately 2 weeks later, patient was in surgery and sedated for surgical intervention to remove the wire. The surgeon was unable to locate the foreign body under fluoro in the or. The rad tech who was operating the fluoro looked at the images from the previous exam. Tech manipulated those images and discovered that the foreign body that was identified was not a foreign body. It was a defect on the x-ray imaging plate. Surgery was then ended. Imaging plate was taken out of service. Defect on imaging plate did not appear on previous films. No other patients affected. Defect on the imaging plate was not visible during/prior to this patient's radiological exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 4176288 |
| MDR Report Key | 4176288 |
| Date Received | 2014-09-26 |
| Date of Report | 2014-09-26 |
| Date of Event | 2014-09-11 |
| Report Date | 2014-09-26 |
| Date Reported to FDA | 2014-09-26 |
| Date Reported to Mfgr | 2014-10-16 |
| Date Added to Maude | 2014-10-16 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FUJIFILM IMAGING PLATE |
| Generic Name | CASSETTE, RADIOGRAPHIC FILM |
| Product Code | IXA |
| Date Received | 2014-09-26 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
| Manufacturer Address | 419 WEST AVE. STAMFORD CT 06902 US 06902 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-09-26 |