MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-14 for MIRADRY SYSTEM MD4000-MC manufactured by Sientra, Inc..
[188689985]
Analysis of treatment data recorded by the system revealed nothing unusual. There were no device performance or user issues observed that would cause the symptom.
Patient Sequence No: 1, Text Type: N, H10
[188689986]
Patient diagnosed with 3cm x 2cm ulceration in axilla approx. 2 weeks post miradry treatment. The patient was treated with aquaphor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008082710-2020-00013 |
| MDR Report Key | 9832770 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-19 |
| Date Mfgr Received | 2019-12-30 |
| Date Added to Maude | 2020-03-14 |
| 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 | 2020-03-14 |
| Model Number | MD4000-MC |
| Catalog Number | MD4000-MC |
| Lot Number | 17H0896 |
| 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 | 2020-03-14 |