MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2003-10-21 for ARTICULATING ARM FOR CEILING MOUNT SYSTEM 5787 manufactured by E-z-em, Inc..
[21716408]
It was reported that the ceiling articulating arm had broken and fell to the floor with the injector attached, bruising the technician's right hand. The arm cracked at the junction where the articulating arm slides on the round shaft of the down column rod. A loaner injector was installed by e-z-em and the customer's unit was returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2411512-2003-00012 |
| MDR Report Key | 491920 |
| Report Source | 05,06,07 |
| Date Received | 2003-10-21 |
| Date of Report | 2003-09-17 |
| Date of Event | 2003-09-17 |
| Date Facility Aware | 2003-09-17 |
| Report Date | 2003-09-22 |
| Date Reported to Mfgr | 2003-09-17 |
| Date Mfgr Received | 2003-09-17 |
| Device Manufacturer Date | 1999-06-01 |
| Date Added to Maude | 2003-10-29 |
| 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 | 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-EM, INC. |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 11590 |
| Single Use | 3 |
| Remedial Action | RP |
| Previous Use Code | 3 |
| 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 | 2003-10-21 |
| Model Number | NA |
| Catalog Number | 5787 |
| Lot Number | 010103833113 |
| ID Number | NA |
| Device Availability | Y |
| Device Age | 51 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 480620 |
| 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 | 2003-10-21 |