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.
[2919171]
Info received indicates that the manufacture and expiration dates on the label are incorrect for one lot of product. The incorrect labeling was reported by the sales rep and there was no pt involvement.
Patient Sequence No: 1, Text Type: D, B5
[10276890]
(b)(4). Analysis: the actual product was evaluated and showed the incorrect dates for manufacture and expiration. Investigation revealed that the supplier's expiration date for one lot of product was inadvertently entered as the manufacture date during re-packaging, and the expiration date was automatically set to 4 years after manufacture, therefore, making both dates incorrect. Conclusion: the event was related to labeling, and there was no pt involvement.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2127690-2006-00004 |
| MDR Report Key | 2783768 |
| Report Source | 01,07 |
| Date Received | 2006-11-15 |
| Date of Report | 2006-10-16 |
| Date of Event | 2006-10-16 |
| Date Mfgr Received | 2006-10-16 |
| Date Added to Maude | 2012-10-16 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | LAURALIE MILIKAN |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7633919124 |
| Manufacturer G1 | MEDTRONIC HEART VALVES |
| Manufacturer Street | 8299 CENTRAL AVE., N.E. |
| Manufacturer City | SPRING LAKE PARK MN 55432357 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55432 3576 |
| Single Use | 3 |
| Remedial Action | RB |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HIGH TEMPERATURE CAUTERY |
| 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 | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC HEART VALVES |
| Manufacturer Address | 8299 CENTRAL AVE., N.E. SPRING LAKE PARK MN 55432357 US 55432 3576 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-11-15 |