MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,other report with the FDA on 2020-02-12 for COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE CV1161 manufactured by Carefusion, Inc.
| Report Number | 1423507-2020-00007 |
| MDR Report Key | 9699688 |
| Report Source | DISTRIBUTOR,OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-03-20 |
| Date of Event | 2020-01-22 |
| Date Mfgr Received | 2020-01-22 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 N. FAIRVIEW DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer Phone | 8015652341 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 5 SUNNEN DRIVE |
| Manufacturer City | ST. LOUIS MO 63143 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 63143 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COSGROVE FLEX QCK-BEND 61MM FOGARTY-TYPE |
| Generic Name | VASCULAR CLAMP |
| Product Code | DXC |
| Date Received | 2020-02-12 |
| Catalog Number | CV1161 |
| Lot Number | L08 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 5 SUNNEN DRIVE ST. LOUIS MO 63143 US 63143 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |