MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2003-01-07 for ARTICULATING ARM FOR CEILING MOUNT SYSTEM 5787 manufactured by E-z-em, Inc..
[298632]
The ct technician was moving the percupump injector following injection and scan. As they moved the ceiling articulating arm, the arm broke off completely at it's attachment site to the down post. The articulating arm hit the technician on the top of the head and on the shoulder. The injector which swung down at the same time hit their lower leg area. They were taken to the e. R. And released to home, and has been seeing their doctor for follow up.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 437328 |
| MDR Report Key | 437328 |
| Date Received | 2003-01-07 |
| Date of Report | 2002-12-05 |
| Date of Event | 2002-12-05 |
| Date Facility Aware | 2002-12-05 |
| Report Date | 2002-12-05 |
| Date Reported to Mfgr | 2002-12-05 |
| Date Added to Maude | 2003-01-15 |
| Event Key | 0 |
| Report Source Code | User Facility 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM FOR CEILING MOUNT SYSTEM |
| Generic Name | CT INJECTOR ACCESSORY |
| Product Code | FIH |
| Date Received | 2003-01-07 |
| Model Number | NA |
| Catalog Number | 5787 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 426264 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 717 MAIN ST. WESTBURY NY 11590 US |
| Baseline Brand Name | ARTICULATING ARM FOR CEILING MOUNT SYSTEM |
| Baseline Generic Name | CT INJECTOR ACCESSORY |
| Baseline Model No | NA |
| Baseline Catalog No | 5787 |
| Baseline ID | NA |
| Baseline Device Family | ACCESSORY FOR PERCUPUMP INJECTOR SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K864227 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2003-01-07 |