MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2019-11-13 for MIRADRY SYSTEM MD4000-MC-HK manufactured by Miradry, Inc..
| Report Number | 3008082710-2019-00088 |
| MDR Report Key | 9319572 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2019-11-13 |
| Date of Report | 2019-10-16 |
| Date of Event | 2019-04-30 |
| Date Mfgr Received | 2019-10-16 |
| Device Manufacturer Date | 2018-08-13 |
| Date Added to Maude | 2019-11-13 |
| 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 | MS. SARA NAKAMURA |
| Manufacturer Street | 2790 WALSH AVENUE |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal | 95051 |
| Manufacturer Phone | 4089408700 |
| Manufacturer G1 | MIRADRY, INC. |
| Manufacturer Street | 2790 WALSH AVENUE |
| Manufacturer City | SANTA CLARA CA 95051 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95051 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MIRADRY SYSTEM |
| Generic Name | MICROWAVE DERMATOLOGIC SYSTEM |
| Product Code | OUB |
| Date Received | 2019-11-13 |
| Model Number | MD4000-MC-HK |
| Catalog Number | MD4000-MC-HK |
| Lot Number | 18H0920-HK |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRADRY, INC. |
| Manufacturer Address | 2790 WALSH AVENUE SANTA CLARA CA 95051 US 95051 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2019-11-13 |