MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-10-06 for MAVIG MAIN ASSEMBLY TS15U11 * manufactured by Ti-ba Enterprises, Inc..
[15147006]
An elderly patient was undergoing cardiac catheterization and coronary angiography. During the course of the procedure the mavig x-ray shield suspension arm broke causing the lead shield to fall on the patient while lying on the cardiac cath lab table. The shield fell on the patient's face, resulting in a right forehead/orbital laceration which ultimately required sutures. Skull fracture and intracranial bleeding were ruled out. Long-term injury unlikely. The device/product failure was the direct cause of the patient's injuries.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1902851 |
| MDR Report Key | 1902851 |
| Date Received | 2010-10-06 |
| Date of Report | 2010-10-06 |
| Date of Event | 2010-09-29 |
| Report Date | 2010-10-06 |
| Date Reported to FDA | 2010-10-06 |
| Date Added to Maude | 2010-11-18 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 | MAVIG |
| Generic Name | RADIATION SHIELD, CEILING MOUNTED |
| Product Code | KPY |
| Date Received | 2010-10-06 |
| Model Number | MAIN ASSEMBLY TS15U11 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TI-BA ENTERPRISES, INC. |
| Manufacturer Address | 25 HYTEC CIRCLE ROCHESTER NY 14606 US 14606 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-10-06 |