MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-10 for 2000 SYSTEM BR-2002 manufactured by Burkhart Roentgen, Inc..
[12830]
Customer attempted to move thyroid radiation sheild, sheild (suspended by ceiling track) fell missing pt on table under exam.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2020563-1993-00016 |
| MDR Report Key | 17242 |
| Date Received | 1994-01-10 |
| Date of Report | 1993-11-29 |
| Date of Event | 1993-11-12 |
| Date Facility Aware | 1993-11-15 |
| Report Date | 1993-11-29 |
| Date Reported to FDA | 1993-11-29 |
| Date Reported to Mfgr | 1993-11-29 |
| 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 | 2000 SYSTEM |
| Generic Name | LENS AND THYROID PROTECTOR |
| Product Code | EAK |
| Date Received | 1994-01-10 |
| Model Number | BR-2002 |
| Catalog Number | BR-2002 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 36 MO |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 17175 |
| Manufacturer | BURKHART ROENTGEN, INC. |
| Manufacturer Address | SUITE 1704 PINELLAS FL 34665 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1994-01-10 |