MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc..
[176666982]
Who gave you info? Pt. What is the complaint about the product? The button on the whisperject is stuck and pt can not administer medication - unk if pt experience any side effects. Was the product taken or administered? No. What is the lot number? Na. Can the mfr call the pt for f/u if necessary? Yes. Can the mfr arrange for product pick up? Yes. Md aware and drug therapy continues unchanged. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092529 |
| MDR Report Key | 9632438 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-10 |
| Date Added to Maude | 2020-01-27 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 2020-01-24 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS, INC. |
| Brand Name | GLATIRAMER ACETATE 40 MG/ML |
| Product Code | --- |
| Date Received | 2020-01-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | MYLAN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |