MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-23 for T-COAT MICRO HDL KERR RONG THIN 8IN 3MM NL4252-83T manufactured by Carefusion, Inc.
| Report Number | 1423507-2019-00007 |
| MDR Report Key | 8540539 |
| Date Received | 2019-04-23 |
| Date of Report | 2019-05-24 |
| Date of Event | 2019-03-26 |
| Date Mfgr Received | 2019-03-26 |
| Date Added to Maude | 2019-04-23 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BDX ANNA WEHRHEIM |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal | 60061 |
| Manufacturer G1 | CAREFUSION, INC |
| Manufacturer Street | 75 NORTH FAIRWAY DRIVE |
| Manufacturer City | VERNON HILLS IL 60061 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60061 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | T-COAT MICRO HDL KERR RONG THIN 8IN 3MM |
| Generic Name | KERRISON RONGEURS |
| Product Code | HAE |
| Date Received | 2019-04-23 |
| Catalog Number | NL4252-83T |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION, INC |
| Manufacturer Address | 75 NORTH FAIRWAY DRIVE VERNON HILLS IL 60061 US 60061 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-04-23 |