MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-06 for MIRADRY SYSTEM MD4000-MC manufactured by Sientra, Inc..
Report Number | 3008082710-2020-00011 |
MDR Report Key | 9803007 |
Report Source | HEALTH PROFESSIONAL |
Date Received | 2020-03-06 |
Date of Report | 2020-03-06 |
Date of Event | 2017-05-17 |
Date Mfgr Received | 2020-01-16 |
Date Added to Maude | 2020-03-06 |
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 | JOANN KUHNE |
Manufacturer Street | 420 S FAIRVIEW AVE. SUITE 200 |
Manufacturer City | SANTA BARBARA, CA |
Manufacturer Country | US |
Manufacturer Phone | 5623500 |
Manufacturer G1 | SIENTRA, INC. |
Manufacturer Street | 420 S FAIRVIEW AVE. SUITE 200 |
Manufacturer City | SANTA BARBARA, CA |
Manufacturer Country | US |
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 | 2020-03-06 |
Model Number | MD4000-MC |
Catalog Number | MD4000-MC |
Operator | HEALTH PROFESSIONAL |
Device Availability | N |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | SIENTRA, INC. |
Manufacturer Address | 420 S FAIRVIEW AVE. SUITE 200 SANTA BARBARA, CA US |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 1. Required No Informationntervention | 2020-03-06 |