MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-06 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc..
[178349356]
I prepared to use the whisperject device (for use with glatiramer acetate), in the hip region on (b)(6) 2020. I pressed the device against the skin, the needle deployed, but i never received the green confirmation check mark. I continued to hold the whisperject device in place for about 40 seconds or so, which typically doesn? T take that long, and no confirmation. Since my positioning was becoming uncomfortable, i ended up removing the device from my skin, and medication squirted out. I don? T believe any of the dose went in. I have since contacted mylan advocate. For additional training, which i have yet to meet with someone. I was previously on copaxone, and didn? T experience any issues with their auto injector device. Fda safety report id # (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092825 |
| MDR Report Key | 9681697 |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-01-17 |
| Date Added to Maude | 2020-02-07 |
| 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 | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WHISPERJECT |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | KZH |
| Date Received | 2020-02-06 |
| Lot Number | 14252001 |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-06 |