MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-01-17 for FREEMIE PUMP FG077 UPC - 730669496646 manufactured by Dao Health.
| Report Number | 3007602316-2020-00001 |
| MDR Report Key | 9604100 |
| Report Source | CONSUMER |
| Date Received | 2020-01-17 |
| Date of Report | 2020-01-16 |
| Date of Event | 2019-12-17 |
| Device Manufacturer Date | 2019-08-14 |
| Date Added to Maude | 2020-01-17 |
| 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 | MR. BRIAN MCCOLLUM |
| Manufacturer Street | 1345 EASY LN. |
| Manufacturer City | EL DORADO HILLS CA 95762 |
| Manufacturer Country | US |
| Manufacturer Postal | 95762 |
| Manufacturer Phone | 9163397388 |
| Manufacturer G1 | WREX PRODUCTS |
| Manufacturer Street | 25 WREX CT |
| Manufacturer City | CHICO CA 95928 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95928 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEMIE PUMP |
| Generic Name | FREEMIE LIBERTY DELUXE SET |
| Product Code | HGX |
| Date Received | 2020-01-17 |
| Model Number | FG077 |
| Catalog Number | UPC - 730669496646 |
| Lot Number | 14.08.19-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DAO HEALTH |
| Manufacturer Address | 1345 EASY LN EL DORADO HILLS CA 95762 US 95762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-01-17 |