MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-09-19 for KENNEX RADIATION SHIELD * manufactured by Siemens Medical Systems, Inc..
[20891884]
Arm and lead shield came off on the mount which suspends from the ceiling. Pt was out of the room, but it just missed hitting an associate who was moving the lead shield out of the way. The arm and shield weigh approx 150 lbs.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1009953 |
| MDR Report Key | 38947 |
| Date Received | 1996-09-19 |
| Date of Report | 1996-07-17 |
| Date of Event | 1996-07-15 |
| Date Added to Maude | 1996-09-23 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | KENNEX RADIATION SHIELD |
| Generic Name | CEILING MOUNTED LEAD SHIELD |
| Product Code | EAK |
| Date Received | 1996-09-19 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 40178 |
| Manufacturer | SIEMENS MEDICAL SYSTEMS, INC. |
| Manufacturer Address | 186 WOOD AVE SOUTH ISELIN NJ 08830 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-09-19 |