MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-24 for AUTOINJECTOR manufactured by Owen Mumford, Ltd..
[181123101]
Pt reported on (b)(6) 2020 that his auto injector for his copaxone has been malfunctioning. It happened twice where it does not injection the medication when he presses the button, but does it at a later time and sprays all the medication out, almost like the spring is getting stuck. Pt may have missed 2 doses due to this.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093230 |
| MDR Report Key | 9750263 |
| Date Received | 2020-02-24 |
| Date of Report | 2020-02-13 |
| Date of Event | 2020-02-13 |
| Date Added to Maude | 2020-02-25 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOINJECTOR |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | KZH |
| Date Received | 2020-02-24 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWEN MUMFORD, LTD. |
| Brand Name | COPAXONE INJ 40MG/ML |
| Product Code | --- |
| Date Received | 2020-02-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICALS USA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-24 |