MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-19 for INSULIN INJECTOR MEDI-JECTOR VISION manufactured by Antares Pharma.
[4179713]
Antares pharma is the mfr of an insulin injection device called 'medi-jector vision' that was approved by the fda and marketed to insulin dependent diabetics. Antares pharma has decided effective (b)(6) 2013 to no longer manufacture the vial adapters for the insulin vials and the disposable 'needle-free syringes' that are required for the use of the medi-jector vision. Would you please let me know what is their obligation for this medical device since i'm dependent on it. Thank you.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034650 |
| MDR Report Key | 3643010 |
| Date Received | 2014-02-19 |
| Date of Report | 2014-02-14 |
| Date of Event | 2013-12-31 |
| Date Added to Maude | 2014-02-25 |
| 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 |
| Reporter Occupation | PATIENT |
| Health Professional | 0 |
| 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 | INSULIN INJECTOR |
| Generic Name | INSULIN INJECTOR |
| Product Code | KZE |
| Date Received | 2014-02-19 |
| Model Number | MEDI-JECTOR VISION |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANTARES PHARMA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-19 |