MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-10-10 for BURKHARDT RADIATION SHIELD 13.2100493225 NA manufactured by Burkhardt Roentgen Intl, Inc..
[30517]
As technologist was reportedly moving the lead shield assembly, which was suspended from a ceiling post, the assembly allegedly fell from the ceiling post supposedly striking the technologist's left forearm and right finger reportedly resulting in abrasions on the left forearm and right finger.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1217116-1996-00001 |
| MDR Report Key | 48914 |
| Date Received | 1996-10-10 |
| Date of Report | 1996-10-10 |
| Date of Event | 1996-10-02 |
| Date Facility Aware | 1996-10-04 |
| Report Date | 1996-10-10 |
| Date Reported to Mfgr | 1996-10-10 |
| Date Added to Maude | 1996-11-18 |
| 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 |
| Reporter Occupation | RADIOLOGIC TECHNOLOGIST |
| 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 RADIATION SHIELD |
| Generic Name | RADIATION SHIELD |
| Product Code | IWQ |
| Date Received | 1996-10-10 |
| Returned To Mfg | 1996-10-10 |
| Model Number | 13.2100493225 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NO INFO |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 49672 |
| Manufacturer | BURKHARDT ROENTGEN INTL, INC. |
| Manufacturer Address | 5201 8TH AVE SOUTH ST PETERSBURG FL 33707 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1996-10-10 |