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 2001-07-02 for ARTICULATING ARM FOR CEILING SUSPENSION SYSTEM 5787 manufactured by E-z-em, Inc..
[17111208]
It was reported that the articulating arm failed (metal appeared sheared or broken) causing the injector to fall and strike the technician's hand. The facility "suspected" that the technician's finger was broken. E-z-em was not provided with information as to whether or not a fracture was confirmed.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2001-00013 |
| MDR Report Key | 341198 |
| Report Source | 05,06,07 |
| Date Received | 2001-07-02 |
| Date of Report | 2001-06-01 |
| Date of Event | 2001-06-01 |
| Date Facility Aware | 2001-06-01 |
| Report Date | 2001-06-01 |
| Date Reported to Mfgr | 2001-06-01 |
| Date Mfgr Received | 2001-06-01 |
| Date Added to Maude | 2001-07-12 |
| 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 | JUDITH MERITZ, VP |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ARTICULATING ARM FOR CEILING SUSPENSION SYSTEM |
| Generic Name | ACCESSORY FOR PERCUPUMP INJECTOR |
| Product Code | FIH |
| Date Received | 2001-07-02 |
| Model Number | NA |
| Catalog Number | 5787 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 330525 |
| 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 | 2001-07-02 |