MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-02-28 for WHISPERJECT manufactured by Mylan Pharmaceuticals, Inc..
[181833244]
Who gave you information? () patient (x) other: rep from mylan. What is the complaint about the product? Whisperject broke. Was the product taken or administered? Yes. What is the lot number? Not available, did not have lot number to provide. Can the manufacturer call the patient for follow up if necessary? Yes. Can the manufacturer arrange for product pick up? Yes. Md aware and drug therapy continues unchanged. Reported to (b)(6) by: health professional.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5093432 |
| MDR Report Key | 9775248 |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-18 |
| Date Added to Maude | 2020-03-02 |
| 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 | 2020-02-28 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MYLAN PHARMACEUTICALS, INC. |
| Product Code | --- |
| Date Received | 2020-02-28 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |