MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2020-01-31 for AUTOJECT manufactured by Owen Mumford, Ltd..
[177676044]
Who gave you info? Pt. What is the complaint about the product? Autoject is getting slow, not always injecting completely. Was the product taken or administered? Yes, sometime. What is the lot number? Unk. Can the mfr call the f/u if necessary? Yes. Can the mfr arrange for product pickup? Yes. Md aware and drug therapy continues unchanged. Unk if pt experience any side effects due to dose not coming out fully. Reported to (b)(6) by pt/caregiver.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5092702 |
| MDR Report Key | 9659260 |
| Date Received | 2020-01-31 |
| Date of Report | 2020-01-24 |
| Date Added to Maude | 2020-02-03 |
| 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 | 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 | 2020-01-31 |
| Device Availability | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWEN MUMFORD, LTD. |
| Brand Name | COPAXONE 40MG/ML |
| Product Code | --- |
| Date Received | 2020-01-31 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-01-31 |