MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-10-16 for * manufactured by United Shield Corp..
[76151]
During a procedure in the cardiac catherization lab; lead radiation shield fell from the ceiling onto the pts chest and abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1012324 |
| MDR Report Key | 127634 |
| Date Received | 1997-10-09 |
| Date of Report | 1997-10-15 |
| Date of Event | 1997-10-09 |
| Date Added to Maude | 1997-10-24 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | * |
| Generic Name | RADIATION SAFETY SHIELD |
| Product Code | IWQ |
| Date Received | 1997-10-16 |
| Model Number | NA |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 124877 |
| Manufacturer | UNITED SHIELD CORP. |
| Manufacturer Address | 243 BOSTON ST TOPSFIELD MA 01983 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1997-10-09 |