MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-10-18 for AGFA ADC COMPACT * manufactured by Agfa Gevaert Ag.
[17430552]
Patient imaged in 2002. An image artifact that may have been generated by the device caused a physician to misdiagnose fractured screws in right femoral fixation device place prior to initial images in february 6, 2002. Diagnosis may have led to patient surgery, during which it was learned that the screws were not fractured. Current evidence is conflicting irrespective of image.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1063474-2002-00001 |
| MDR Report Key | 425668 |
| Report Source | 05,06 |
| Date Received | 2002-10-18 |
| Date of Report | 2002-10-18 |
| Date of Event | 2002-08-07 |
| Date Mfgr Received | 2002-09-19 |
| Device Manufacturer Date | 1998-03-01 |
| Date Added to Maude | 2002-11-05 |
| 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 | 0 |
| Manufacturer Contact | JEFF JEDLICKA, MGR. |
| Manufacturer Street | 10 SOUTH ACADEMY STREET |
| Manufacturer City | GREENSVILLE SC 29601 |
| Manufacturer Country | US |
| Manufacturer Postal | 29601 |
| Manufacturer Phone | 8644211815 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AGFA |
| Generic Name | COMPUTED RADIOGRAPHY |
| Product Code | JAI |
| Date Received | 2002-10-18 |
| Model Number | ADC COMPACT |
| Catalog Number | * |
| Lot Number | * |
| ID Number | SOFTWARE V1312 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 414719 |
| Manufacturer | AGFA GEVAERT AG |
| Manufacturer Address | MAX PLANCK STRASSE PEISSENBERG GM D82380 |
| Baseline Brand Name | AGFA |
| Baseline Generic Name | COMPUTED RADIOGRAPHY |
| Baseline Model No | ADC COMPACT |
| Baseline Catalog No | * |
| Baseline ID | SOFTWARE V1312 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2002-10-18 |