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 2020-02-14 for AUTOJECT 2 FOR GLASS SYRINGE AJ 1060 AJ1060 manufactured by Owen Mumford Limited.
[188329124]
Medwatch mw5092077 received and the only information is that the "pt's wife reported that the pt's autoject2 has not been working properly. She is going to contact the mfr's hub to obtain a new one. " there is no other information, no contact information, no information regarding how the device is not working properly or any information as to who the initial reporter was.
Patient Sequence No: 1, Text Type: N, H10
[188329125]
Patient's wife reported that his autoject has not been working properly. No other details were given other than she was contact the manufacturer's hub to obtain a new one.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8021764-2020-00003 |
| MDR Report Key | 9712127 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-02-14 |
| Date of Report | 2020-02-14 |
| Date Facility Aware | 2020-01-17 |
| Report Date | 2020-02-14 |
| Date Reported to FDA | 2020-02-14 |
| Date Reported to Mfgr | 2020-01-17 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. PATTY CRONAN |
| Manufacturer Street | 1755 WEST OAK COMMONS CT. |
| Manufacturer City | MARIETTA, GA |
| Manufacturer Country | US |
| Manufacturer Phone | 977222613 |
| Manufacturer G1 | OWEN MUMFORD LIMITED |
| 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 | 2020-02-14 |
| 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 LIMITED |
| Manufacturer Address | BROOK HILL WOODSTOCK, OXFORDSHIRE OX201TU UK OX20 1TU |
| Brand Name | COPAXONE 40MG/ML |
| Product Code | --- |
| Date Received | 2020-02-14 |
| Device Sequence No | 101 |
| Device Event Key | 0 |
| Manufacturer | TEVA PHARMACEUTICAL |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-14 |