MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-09-13 for MAVIG OT256V50 * manufactured by Siemens Medical.
[20526448]
When moving the lead shield into place during a patient procedure, the shield dismantled from the base on the ceiling and fell to the ground striking the physician user, causing injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 555005 |
| MDR Report Key | 555005 |
| Date Received | 2004-09-13 |
| Date of Report | 2004-09-13 |
| Date of Event | 2004-08-19 |
| Report Date | 2004-09-13 |
| Date Reported to FDA | 2004-09-13 |
| Date Added to Maude | 2004-11-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MAVIG |
| Generic Name | LEAD SHIELD |
| Product Code | IWQ |
| Date Received | 2004-09-13 |
| Model Number | OT256V50 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 544641 |
| Manufacturer | SIEMENS MEDICAL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-09-13 |