MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-24 for AUTOJECT manufactured by Owen Mumford Usa, Inc..
[176651270]
Pt reports that the autoject took a long time to deploy on (b)(6) 2020. Was the product taken / administered? Yes. Can mfr call pt for f/u? Yes. Can mfr arrange for product pick up? Yes. Md aware and drug therapy continues unchanged. No further info provided. No adverse event experienced. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092528 |
| MDR Report Key | 9632435 |
| Date Received | 2020-01-24 |
| Date of Report | 2020-01-13 |
| Date of Event | 2020-01-13 |
| 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 | AUTOJECT |
| Generic Name | INTRODUCER, SYRINGE NEEDLE |
| Product Code | KZH |
| Date Received | 2020-01-24 |
| Device Availability | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWEN MUMFORD USA, INC. |
| Brand Name | COPAXONE 40MG/ML |
| Product Code | --- |
| Date Received | 2020-01-24 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-24 |