MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-06 for ENDO STRATUS IRRIGATION PUMP manufactured by Medivators.
| Report Number | 2150060-2019-00070 |
| MDR Report Key | 9288225 |
| Date Received | 2019-11-06 |
| Date of Report | 2019-11-06 |
| Date of Event | 2019-10-07 |
| Date Mfgr Received | 2019-10-07 |
| Device Manufacturer Date | 2017-02-22 |
| Date Added to Maude | 2019-11-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | LAUREN JOHNSON |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal | 55447 |
| Manufacturer G1 | MEDIVATORS |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | PLYMOUTH MN 55447 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55447 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | ENDO STRATUS IRRIGATION PUMP |
| Generic Name | ENDOSCOPIC IRRIGATION PUMP |
| Product Code | OCX |
| Date Received | 2019-11-06 |
| Returned To Mfg | 2019-10-16 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N PLYMOUTH MN 55447 US 55447 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-11-06 |