MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-12-03 for RAYSHIELD CAN/CSA 0222 UL manufactured by Aadco Medical.
[20243157]
Ceiling mounted x-ray lead shield fell off the attachment arm while pt was on the table, during an angiogram case. Shield fell to the floor and broke. Nobody was hurt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5013821 |
| MDR Report Key | 1552724 |
| Date Received | 2009-12-03 |
| Date of Report | 2009-12-03 |
| Date of Event | 2009-11-25 |
| Date Added to Maude | 2009-12-11 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAYSHIELD |
| Generic Name | CEILING MOUNTED LEAD SHIELD |
| Product Code | EAK |
| Date Received | 2009-12-03 |
| Catalog Number | CAN/CSA 0222 UL |
| Lot Number | 601-M90 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AADCO MEDICAL |
| Manufacturer Address | RANDOLPH VT US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-12-03 |