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..
[188691277]
Analysis of treatment data recorded by the system revealed nothing unusual. There were no device performance or user issues observed that would cause the symptoms. The rate of abscess seen (92 worldwide reportable incidents out of estimated 200,000+ procedures performed to date) is approximately 0. 045% of the procedures and within the acceptable range as identified in risk analysis documentation.
Patient Sequence No: 1, Text Type: N, H10
[188691278]
Post miradry treatment, patient developed left side abscess, positive for staph infection. The right side axilla developed a 2cm deep ulceration. The abscess was drained and treated with anti-biotics and compress. The ulceration was cleaned with a q-tip and treated with aquaphor.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008082710-2020-00014 |
| MDR Report Key | 9832775 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-14 |
| Date of Report | 2020-03-13 |
| Date of Event | 2019-12-27 |
| Date Mfgr Received | 2020-01-27 |
| 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 |