MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2000-09-01 for BURKHART ROENTGEN RADIATION SHIELD BK2001 NA manufactured by Burkhart Roentgen Int'l, Inc..
[181828]
Reportedly, during a procedure, the radiation shield detached from its suspension arm and fell, striking the pt's arm and the radiologist's wrist. The radiologist sustained a hairline fracture of his wrist. The extend of injury, if any, to the pt is unk at this time. Reportedly, the radiationshield fell due to a broken weld on the yoke which holds the shield on the suspension arm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW4002840 |
| MDR Report Key | 295318 |
| Date Received | 2000-09-01 |
| Date of Report | 2000-09-01 |
| Date of Event | 2000-08-14 |
| Date Added to Maude | 2000-09-14 |
| 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 | BURKHART ROENTGEN RADIATION SHIELD |
| Generic Name | PERSONNEL PROTECTIVE SHIELD |
| Product Code | IWQ |
| Date Received | 2000-09-01 |
| Model Number | BK2001 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 285846 |
| Manufacturer | BURKHART ROENTGEN INT'L, INC. |
| Manufacturer Address | 5201 8TH AVE SOUTH ST. PETERSBURG FL 33707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-09-01 |