MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-03-31 for MICROVISION CI 592 * manufactured by Agfa Corp..
[179249]
The film reportedly exhibited low density artifacts which supposedly could resemble micro-calcifications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063474-2000-00001 |
| MDR Report Key | 272559 |
| Report Source | 05 |
| Date Received | 2000-03-31 |
| Date of Report | 2000-03-31 |
| Date of Event | 2000-02-21 |
| Date Facility Aware | 2000-02-21 |
| Report Date | 2000-03-31 |
| Date Mfgr Received | 2000-02-21 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2000-04-10 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIMOTHY CAPEHART |
| Manufacturer Street | 10 SOUTH ACADEMY ST |
| Manufacturer City | GREENVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211834 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MICROVISION CI |
| Generic Name | RADIOGRAPHIC FILM |
| Product Code | IWZ |
| Date Received | 2000-03-31 |
| Model Number | 592 |
| Catalog Number | * |
| Lot Number | 9091-0341-04, 9081-0584-01 |
| ID Number | * |
| Device Expiration Date | 2001-09-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 263864 |
| Manufacturer | AGFA CORP. |
| Manufacturer Address | STANTON ROAD BREVARD NC * US |
| Baseline Brand Name | MICROVISION CI |
| Baseline Generic Name | RADIOGRAPHIC FILM |
| Baseline Model No | 592 |
| Baseline Device Family | MICROVISION |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2000-03-31 |