MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-20 for CEILING MOUNTED LEAD SHIELD/HOLDER 13-804158712 manufactured by Toshiba America Medical Systems, Inc..
[15481471]
While moving the ceiling mounted lead shield away from the pt, the arm ball joint sheared in two, hitting the employee in the left arm and elbow. No fractures present, employee experiencing severe tendonitis/soreness. Co serviced equipment one week prior to incident, because it had become difficult to move. Co had lubricated this joint, but rptr wonders if it was metal fatigue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009331 |
| MDR Report Key | 33561 |
| Date Received | 1996-06-20 |
| Date of Report | 1996-02-28 |
| Date of Event | 1996-02-22 |
| Date Added to Maude | 1996-06-24 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CEILING MOUNTED LEAD SHIELD/HOLDER |
| Generic Name | LEAD SHIELD HOLDER |
| Product Code | EAK |
| Date Received | 1996-06-20 |
| Model Number | 13-804158712 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 34913 |
| Manufacturer | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 2441 MICHELLE DR TUSTIN CA 926812068 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1996-06-20 |