MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2000-02-16 for ELITE 1500E 021-04-002 1280B manufactured by Fischer Imaging Corp..
[206098]
In the course of an initial scout radiograph (lower gi w/barium enema), a pt inadvertently stuck his finger into a mechanical track on which the fluoro tower runs, suffering a sever avulsion injury. The pt was positioned supine on the table for the exam. Pt was asked to roll left pt's left arm extended beyond the table, then roll back. This rolling motion back and forth occurred several times at the physician direction when on one rotation the pt's little finger entered the opening in side of the fluoro tower.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418957-2000-00002 |
| MDR Report Key | 263434 |
| Report Source | 07 |
| Date Received | 2000-02-16 |
| Date of Report | 2000-02-16 |
| Date of Event | 1999-12-28 |
| Date Mfgr Received | 2000-01-19 |
| Device Manufacturer Date | 1995-12-01 |
| Date Added to Maude | 2000-02-23 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | JANET PRIEUR |
| Manufacturer Street | 12300 N. GRANT ST. |
| Manufacturer City | DENVER CO 80241 |
| Manufacturer Country | US |
| Manufacturer Postal | 80241 |
| Manufacturer Phone | 3034526800 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELITE 1500E |
| Generic Name | RADIOGRAPHIC SYSTEM |
| Product Code | ITY |
| Date Received | 2000-02-16 |
| Model Number | 021-04-002 |
| Catalog Number | 1280B |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 255020 |
| Manufacturer | FISCHER IMAGING CORP. |
| Manufacturer Address | 12300 NORTH GRANT ST. DENVER CO 80241 US |
| Baseline Brand Name | ELITE 1500E |
| Baseline Generic Name | RADIOGRAPHIC SYSTEM |
| Baseline Model No | 021-04-002 |
| Baseline Catalog No | 1280B |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-02-16 |