MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-04-28 for RAYSHIELD S-596NR * manufactured by Aadco Medical.
[19548950]
Suspended radiation shield fell off the horizontal arm that was holding it in place. It fell to the floor but did not hit anything. It did not come into contact with patient or personnel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 722606 |
| MDR Report Key | 722606 |
| Date Received | 2006-04-28 |
| Date of Report | 2006-04-28 |
| Date of Event | 2006-04-17 |
| Report Date | 2006-04-28 |
| Date Reported to FDA | 2006-04-28 |
| Date Added to Maude | 2006-06-07 |
| 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 | 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 | RAYSHIELD |
| Generic Name | XRAY, SYSTEM, LEADED SCREEN |
| Product Code | KPY |
| Date Received | 2006-04-28 |
| Model Number | S-596NR |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 711676 |
| Manufacturer | AADCO MEDICAL |
| Manufacturer Address | PO BOX 410 CATAMOUNT COMMERCIAL PARK RT. RANDOLPH VT 05060 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-04-28 |