MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-07-03 for ULTRA Q REFLEX LQP3106-U manufactured by Ellex Medical Pty Ltd.
| Report Number | 3002806902-2019-00004 |
| MDR Report Key | 8756620 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-07-03 |
| Date of Report | 2019-07-15 |
| Date of Event | 2019-06-04 |
| Date Mfgr Received | 2019-07-08 |
| Device Manufacturer Date | 2016-02-10 |
| Date Added to Maude | 2019-07-03 |
| 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 | MR. ANDREW PFEIFFER |
| Manufacturer Street | 3-4 SECOND AVENUE |
| Manufacturer City | MAWSON LAKES, SOUTH AUSTRALIA 5095 |
| Manufacturer Country | AS |
| Manufacturer Postal | 5095 |
| Manufacturer G1 | ELLEX MEDICAL PTY LTD |
| Manufacturer Street | 3-4 SECOND AVENUE |
| Manufacturer City | MAWSON LAKES, 5095 |
| Manufacturer Country | AS |
| Manufacturer Postal Code | 5095 |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ULTRA Q REFLEX |
| Generic Name | OPHTHALMIC LASER |
| Product Code | HQF |
| Date Received | 2019-07-03 |
| Returned To Mfg | 2019-07-01 |
| Model Number | LQP3106-U |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 41 MO |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ELLEX MEDICAL PTY LTD |
| Manufacturer Address | 3-4 SECOND AVENUE MAWSON LAKES, 5095 AS 5095 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-07-03 |