MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-16 for WHISPERJECT manufactured by Mylan Pharmaceuticals Inc..
[183949145]
The pt missed 1 dose of glatiramer due to incorrect depth setting on whisperject device.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093779 |
| MDR Report Key | 9840354 |
| Date Received | 2020-03-16 |
| Date of Report | 2020-03-13 |
| Date of Event | 2020-03-13 |
| Date Added to Maude | 2020-03-17 |
| 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 |
| Reporter Occupation | UNKNOWN |
| 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 | WHISPERJECT |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | KZH |
| Date Received | 2020-03-16 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS INC. |
| Brand Name | GLATIRAMER 40 MG PFS (12/BOX) |
| Product Code | --- |
| Date Received | 2020-03-16 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-16 |