MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-30 for WHISPERJECT DEVICE manufactured by Mylan Pharmaceuticals Inc..
[185930551]
Pt had difficulty resetting the whisperject autoinjector. Reviewed the step to reset the autoinjector so the white mark inside the green box is no longer visible. Pt stated she should be okay for the next injection. Provided pt number to mylan (mfg) (b)(4) for more info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093978 |
| MDR Report Key | 9903070 |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-26 |
| Date Added to Maude | 2020-03-31 |
| 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 | PHARMACIST |
| 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 DEVICE |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | DYB |
| Date Received | 2020-03-30 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS INC. |
| Product Code | --- |
| Date Received | 2020-03-30 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |