MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-05-18 for BURKHARDT-ROENTGEN RAD SHIELD UNKNOWN manufactured by Burkhart-roentgen.
[12833]
It was reported to g. E. That the lead sheild and arm assembly failed and fell on a hospital employee. Reportedly, the ceiling mount broke at the lead sheild pivot. Evidently, the falling assembly struck the employee in the forehead causing a laceration that required stiches. Apparently, the employee also had muscle spasms in the neck, however, x-rays of the head and spine did not reveal any fractures. Apparently, the shield had collided with the c-arm gantry previiiously, however, it is unknown if a collision had occurred during this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126677-1994-00009 |
| MDR Report Key | 17257 |
| Date Received | 1994-05-18 |
| Date of Report | 1994-05-02 |
| Date of Event | 1994-04-20 |
| Date Facility Aware | 1994-04-20 |
| Report Date | 1994-05-02 |
| Date Reported to FDA | 1994-05-02 |
| Date Added to Maude | 1994-10-28 |
| Event Key | 0 |
| Report Source Code | Distributor 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 | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BURKHARDT-ROENTGEN RAD SHIELD |
| Generic Name | SUSPENDED RADIATION SHEILD |
| Product Code | EAK |
| Date Received | 1994-05-18 |
| Model Number | UNKNOWN |
| Catalog Number | UNKNOWN |
| Lot Number | UNKNOWN |
| ID Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | 12 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17189 |
| Manufacturer | BURKHART-ROENTGEN |
| Manufacturer Address | 6571 43RD STREET, NORTH UNIT 7-CHANNEL 4 PINELLAS PARK FL 34665 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1994-05-18 |