MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-02-21 for MIRADRY SYSTEM MN-MD4000-MC-GB manufactured by Miradry, A Sientra Company.
[180784310]
Patient experienced redness and swelling, was started on augmentin 625mg tds for 1 week, by day 3 the redness around the arm was spreading and the mass was fluctuant. Patient was admitted to the new (b)(6). Under general anaesthesia the md carried out an incision and drainage of the abscess, which was the size of a grape, and packed with betadine and gauze. Patient was discharged the following morning after redness had resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008082710-2020-00008 |
| MDR Report Key | 9742452 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-02-21 |
| Date of Report | 2020-02-21 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-01-23 |
| Date Added to Maude | 2020-02-21 |
| 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 | 2020-02-21 |
| Model Number | MN-MD4000-MC-GB |
| Catalog Number | MN-MD4000-MC-GB |
| Lot Number | 17H0292 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MIRADRY, A SIENTRA COMPANY |
| Manufacturer Address | 420 S FAIRVIEW AVE. SUITE 200 SANTA BARBARA, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-02-21 |