MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-08-15 for BURKHART ROENTGEN, INC. * manufactured by Burkhart Roentgen, Inc..
[22073451]
The x-ray shield suspended above table fell at teh foot of the table. Pt was not injured. The shield fell as it was being moved. Weld broke at the base of the post.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 91555 |
| MDR Report Key | 91555 |
| Date Received | 1994-08-15 |
| Date of Report | 1994-03-24 |
| Date of Event | 1994-03-18 |
| Date Facility Aware | 1994-03-18 |
| Report Date | 1994-03-24 |
| Date Reported to Mfgr | 1994-03-24 |
| Date Added to Maude | 1997-05-20 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| 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 | BURKHART ROENTGEN, INC. |
| Generic Name | X-RAY SHIELD |
| Product Code | IWQ |
| Date Received | 1994-08-15 |
| Model Number | * |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 90441 |
| Manufacturer | BURKHART ROENTGEN, INC. |
| Manufacturer Address | 6571 43RD ST, NORTH UNIT 1704 PINELLAS PARK FL 34665 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-08-15 |