MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-02-18 for SAALT REGULAR BLUE manufactured by Saalt, Llc.
| Report Number | 3014276660-2020-20016 |
| MDR Report Key | 9720693 |
| Report Source | CONSUMER |
| Date Received | 2020-02-18 |
| Date of Report | 2020-01-31 |
| Date of Event | 2019-04-13 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2020-02-18 |
| 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 | DANIELLE BURDEN |
| Manufacturer Street | 6149 N MEEKER PL SUITE 110 |
| Manufacturer City | BOISE ID 83713 |
| Manufacturer Country | US |
| Manufacturer Postal | 83713 |
| Manufacturer Phone | 8013682646 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SAALT |
| Generic Name | REGULAR BLUE |
| Product Code | HHE |
| Date Received | 2020-02-18 |
| Model Number | REGULAR BLUE |
| Lot Number | 1218RB |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SAALT, LLC |
| Manufacturer Address | 6149 N MEEKER PL SUITE 110 BOISE ID 83713 US 83713 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-18 |