MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-06 for GE - L/F 801437686 * manufactured by *.
[19261489]
Lead glass shield became loose and unattached from ceiling mounted counterpoise, allowing shield to fall, tech pushed shield away, keeping it from hitting pt at full force. Shield did graze pt requiring x-ray for possible injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 538567 |
| MDR Report Key | 538567 |
| Date Received | 2004-08-06 |
| Date Facility Aware | 2004-07-19 |
| Report Date | 2004-08-05 |
| Date Reported to FDA | 2004-08-05 |
| Date Added to Maude | 2004-08-13 |
| 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 | 3 |
| 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 | GE - L/F |
| Generic Name | LEAD SHIELD (PLEXIGLASS) |
| Product Code | EAK |
| Date Received | 2004-08-06 |
| Model Number | 801437686 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 527833 |
| Manufacturer | * |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2004-08-06 |