MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-03-30 for STABILIZER * 507-914X manufactured by Cordis Corporation.
[4526499]
When the balance wire was removed, it had unraveled. The device remained intact with no retained pieces.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3792622 |
| MDR Report Key | 3792622 |
| Date Received | 2014-03-30 |
| Date of Report | 2014-03-30 |
| Date of Event | 2013-11-13 |
| Report Date | 2014-03-30 |
| Date Reported to FDA | 2014-03-30 |
| Date Reported to Mfgr | 2014-04-08 |
| Date Added to Maude | 2014-05-06 |
| 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 | STABILIZER |
| Generic Name | WIRE, GUIDE, CATHETER |
| Product Code | DOX |
| Date Received | 2014-03-30 |
| Model Number | * |
| Catalog Number | 507-914X |
| Lot Number | 70.613483 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CORDIS CORPORATION |
| Manufacturer Address | 14201 NW 60TH AVENUE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-03-30 |