MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2001-03-12 for AFP * 857000001 manufactured by Afp Imaging Corp.
[197349]
Soft film cassettes for panoramic x-ray systems are not light tight. X-ray film is fogged within 5 mins when casette is removed from the darkroom, complainant has worked with supplier and has determined that 10 units all had the same problem. At the request of afp, a comparison was made with a competitor's (gendex) product; the gendex product was light tight. Afp cassette is used with lanex regular screens and e-mat-g film. The 6/12" size is used on a kaykor panaramic x-ray system.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002959 |
| MDR Report Key | 320254 |
| Date Received | 2001-03-12 |
| Date of Report | 2001-02-15 |
| Date Added to Maude | 2001-03-15 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AFP |
| Generic Name | SOFT FILM CASSETTE, 6X12" FOR PANORAMIC X-RAY SYSTEM |
| Product Code | IXA |
| Date Received | 2001-03-12 |
| Model Number | * |
| Catalog Number | 857000001 |
| Lot Number | * |
| ID Number | * |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 309778 |
| Manufacturer | AFP IMAGING CORP |
| Manufacturer Address | 250 CLEARBROOK RD ELMSFORD NY 10523 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2001-03-12 |