MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-03-29 for * 1624520 manufactured by Handel.
[442114]
Pt prepped for cardiac cath. Md at bedside for procedure. Lead shield and arm cracked from ceiling mount and fell on floor. Shield did not hit anyone or anything but the floor. Pt needed to be reprepped and redraped for procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1038363 |
| MDR Report Key | 697480 |
| Date Received | 2006-03-29 |
| Date of Report | 2006-03-29 |
| Date of Event | 2006-03-24 |
| Date Added to Maude | 2006-04-11 |
| 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 | 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 | LEAD SHIELD, CEILING MOUNTED |
| Product Code | EAK |
| Date Received | 2006-03-29 |
| Model Number | 1624520 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 686573 |
| Manufacturer | HANDEL |
| Manufacturer Address | * * * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-03-29 |