MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-02-06 for AUTOJECT 2 FOR GLASS SYRINGE AJ 1060 AJ1060 manufactured by Owen Mumford Ltd.
| Report Number | 8021764-2020-00002 |
| MDR Report Key | 9679167 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-06 |
| Date of Report | 2020-02-06 |
| Date Facility Aware | 2020-01-06 |
| Report Date | 2020-02-06 |
| Date Reported to FDA | 2020-02-06 |
| Date Reported to Mfgr | 2020-01-07 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-06 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | MS. PATTY CRONAN |
| Manufacturer Street | 1755 WEST OAK COMMONS CT. |
| Manufacturer City | MARIETTA GA 30062 |
| Manufacturer Country | US |
| Manufacturer Postal | 30062 |
| Manufacturer Phone | 7709772226 |
| Manufacturer G1 | OWEN MUMFORD LTD |
| Manufacturer Street | BROOK HILL |
| Manufacturer City | WOODSTOCK, OXFORDSHIRE OX201TU |
| Manufacturer Country | UK |
| Manufacturer Postal Code | OX20 1TU |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOJECT 2 FOR GLASS SYRINGE |
| Generic Name | AUTOINJECTOR |
| Product Code | KZH |
| Date Received | 2020-02-06 |
| Model Number | AJ 1060 |
| Catalog Number | AJ1060 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | OWEN MUMFORD LTD |
| Manufacturer Address | BROOK HILL WOODSTOCK, OXFORDSHIRE OX201TU UK OX20 1TU |
| Brand Name | COPAXONE 40MG/ML |
| Product Code | --- |
| Date Received | 2020-02-06 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICALS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-06 |