MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-01-10 for UNIVERSAL 3306A T NA manufactured by Del Medical Imaging.
[16784276]
Tubestand rolled off of its floor track allowing it to fall towards the floor. Stop brackets on floor track were not in place at the time of this incident. Technologist received a fractured hand and a bruised foot. No patient was involved in this incident.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1418964-2002-00001 |
| MDR Report Key | 371326 |
| Report Source | 08 |
| Date Received | 2002-01-10 |
| Date of Report | 2002-01-10 |
| Date of Event | 2002-01-03 |
| Date Mfgr Received | 2002-01-04 |
| Device Manufacturer Date | 1986-12-01 |
| Date Added to Maude | 2002-01-16 |
| 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 | BILL ENGEL |
| Manufacturer Street | 11550 W KING STREET |
| Manufacturer City | FRANKLIN PARK IL 60131 |
| Manufacturer Country | US |
| Manufacturer Postal | 60131 |
| Manufacturer Phone | 8472887000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | MA |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | UNIVERSAL |
| Generic Name | TUBESTAND |
| Product Code | IYB |
| Date Received | 2002-01-10 |
| Model Number | 3306A T |
| Catalog Number | NA |
| Lot Number | 12/86 |
| ID Number | FAMILY "TUBESTAND" |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 360449 |
| Manufacturer | DEL MEDICAL IMAGING |
| Manufacturer Address | 11550 WEST KING ST. FRANKLIN PARK IL 60131 US |
| Baseline Brand Name | UNIVERSAL |
| Baseline Generic Name | TUBESTAND |
| Baseline Model No | 3306A T |
| Baseline Catalog No | NA |
| Baseline ID | FAMILY "TUBESTA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-01-10 |