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 2019-11-08 for MIRADRY SYSTEM MD4000-MC manufactured by Miradry, Inc..
Report Number | 3008082710-2019-00085 |
MDR Report Key | 9297599 |
Report Source | COMPANY REPRESENTATIVE,CONSUM |
Date Received | 2019-11-08 |
Date of Report | 2019-10-11 |
Date of Event | 2019-06-27 |
Date Mfgr Received | 2019-10-11 |
Device Manufacturer Date | 2018-06-19 |
Date Added to Maude | 2019-11-08 |
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 | 2019-11-08 |
Model Number | MD4000-MC |
Catalog Number | MD4000-MC |
Lot Number | 18H0575 |
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 | 2019-11-08 |