MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-03-02 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc..
[182217351]
Pt reports that one of the needles broke when opening the package to release the syringe. The packing was glued together "too well" as they opened it broke. He used another one, so was not delayed. Lot number of the box not available. Threw it away.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093472 |
| MDR Report Key | 9779694 |
| Date Received | 2020-03-02 |
| Date of Report | 2020-02-04 |
| Date of Event | 2020-02-03 |
| Date Added to Maude | 2020-03-03 |
| 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 | 2020-03-02 |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS, INC. |
| Brand Name | GLATIRAMER 20MG PFS INJ (30/BOX) |
| Product Code | --- |
| Date Received | 2020-03-02 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-02 |