MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,07 report with the FDA on 2006-11-15 for HIGH TEMPERATURE CAUTERY 6522 6522JM manufactured by Medtronic Heart Valves.
| Report Number | 2127690-2006-60004 |
| MDR Report Key | 788258 |
| Report Source | 01,07 |
| Date Received | 2006-11-15 |
| Date of Report | 2006-10-16 |
| Date of Event | 2006-10-16 |
| Date Facility Aware | 2006-10-16 |
| Report Date | 2006-10-16 |
| Date Reported to Mfgr | 2006-10-16 |
| Date Mfgr Received | 2006-10-16 |
| Device Manufacturer Date | 2006-01-01 |
| Date Added to Maude | 2006-12-01 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAURALIE MILLIKAN |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919124 |
| Manufacturer G1 | MEDTRONIC HEART VALVES |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | SPRING LAKE PARK MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH TEMPERATURE CAUTERY |
| Generic Name | HQP |
| Product Code | HQP |
| Date Received | 2006-11-15 |
| Returned To Mfg | 2006-11-02 |
| Model Number | 6522 |
| Catalog Number | 6522JM |
| Lot Number | B13050 |
| ID Number | NA |
| Device Expiration Date | 2010-01-01 |
| Operator | OTHER |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 775995 |
| Manufacturer | MEDTRONIC HEART VALVES |
| Manufacturer Address | 8299 CENTRAL AVE., N.E. SPRING LAKE PARK MN 55432 US |
| Baseline Brand Name | HIGH TEMPERATURE CAUTERY |
| Baseline Generic Name | HQP |
| Baseline Model No | 6522 |
| Baseline Catalog No | 6522JM |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-11-15 |