MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2002-08-09 for ARTICULATING ARM FOR CEILING MOUNT SYSTEM 5787 manufactured by E-z-em, Inc..
[249435]
Facility reported that the head clamp's retaining screw that secures the injector to the head clamp assembly was not properly seated. This caused the injector to fall out the head clamp, sending the mounting arm and articulating arm to the ceiling. Ct tech received a few bruises and grease on their clothing upon catching the injector, but did not require medical attention. Injector system was reinstalled and is working properly.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2002-00013 |
| MDR Report Key | 410577 |
| Report Source | 05,06 |
| Date Received | 2002-08-09 |
| Date of Report | 2002-07-09 |
| Date of Event | 2002-07-09 |
| Date Facility Aware | 2002-07-09 |
| Report Date | 2002-07-09 |
| Date Reported to Mfgr | 2002-07-09 |
| Date Mfgr Received | 2002-07-09 |
| Device Manufacturer Date | 2001-01-01 |
| Date Added to Maude | 2002-08-19 |
| 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 | GINA VOGELSBERG, MGR |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | E-Z-M, INC. |
| Manufacturer Street | 113-117 MAGNOLIA AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM FOR CEILING MOUNT SYSTEM |
| Generic Name | ST INJECTOR ACCESSORY |
| Product Code | FIH |
| Date Received | 2002-08-09 |
| Model Number | NA |
| Catalog Number | 5787 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 399588 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 113-117 MAGNOLIA AVE. 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 | 2002-08-09 |