MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for ASC425001RH manufactured by Medline Renewal.
| Report Number | 3032391-2020-00002 |
| MDR Report Key | 9771379 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-03-03 |
| Date of Event | 2020-01-28 |
| Date Mfgr Received | 2020-02-03 |
| Date Added to Maude | 2020-02-28 |
| 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 | NIGEL VILCHES |
| Manufacturer Street | THREE LAKES DRIVE |
| Manufacturer City | NORTHFIELD, IL |
| Manufacturer Country | US |
| Manufacturer Phone | 9311458 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | ASC 4250-01 @SUPER TURBOVAC 90, 90 DEGRE |
| Product Code | NUJ |
| Date Received | 2020-02-28 |
| Returned To Mfg | 2020-02-25 |
| Catalog Number | ASC425001RH |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDLINE RENEWAL |
| Manufacturer Address | 1500 NE HEMLOCK AVENUE REDMOND, OR US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-28 |