MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2010-04-01 for NOVO NORDISK AUTO COVER NEEDLES manufactured by Novo Nordisk.
[1298446]
The safety mechanism did not turn to red after injection was given. After auto cover was manipulated and after several attempts before it locked. Dates of use: (b) (6) 2010. Diagnosis or reason for use: insulin pen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5015413 |
| MDR Report Key | 1651101 |
| Date Received | 2010-04-01 |
| Date Added to Maude | 2010-04-09 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NOVO NORDISK AUTO COVER NEEDLES |
| Generic Name | AUTO COVER NEEDLES |
| Product Code | KZE |
| Date Received | 2010-04-01 |
| Lot Number | 09H06U |
| Device Expiration Date | 2012-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NOVO NORDISK |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-04-01 |