MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-11 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc.
[183689188]
Pt stated had issue with whisperject that caused medication to cause a very painful large red welp at injection site where "it looked like it busted open in the middle".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093706 |
| MDR Report Key | 9824496 |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-09 |
| Date of Event | 2020-03-09 |
| Date Added to Maude | 2020-03-12 |
| 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 | WHISPERJECT |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | KZH |
| Date Received | 2020-03-11 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS, INC |
| Brand Name | GLATIRAMER 40MG PFS INJ (12/BOX) |
| Product Code | --- |
| Date Received | 2020-03-11 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MYLAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |