MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-11 for RAPICIDE PA HIGH LEVEL DISINFECTANT ML02-0117 manufactured by Medivators.
| Report Number | 2150060-2020-00007 |
| MDR Report Key | 9695057 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-11 |
| Date of Report | 2020-02-11 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-11 |
| 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 | LAURIE WEIR |
| Manufacturer Street | 9800 59TH AVE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Manufacturer Phone | 8984328 |
| Manufacturer G1 | MEDIVATORS, INC. |
| Manufacturer Street | 14605 28TH AVE N |
| Manufacturer City | MINNEAPOLIS, MN |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RAPICIDE PA HIGH LEVEL DISINFECTANT |
| Generic Name | HIGH LEVEL DISINFECTANT |
| Product Code | FEB |
| Date Received | 2020-02-11 |
| Model Number | ML02-0117 |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDIVATORS |
| Manufacturer Address | 14605 28TH AVE N MINNEAPOLIS, MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-11 |