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 2020-01-08 for MIRADRY SYSTEM MD4000-MC manufactured by Miradry, Inc..
[174695723]
Review of lot history records for the involved device confirmed manufacturing steps and processes were met and followed. Product met final inspection and testing requirements prior to shipment. The rate seen (86 worldwide reportable incidents out of estimated 223,000+ procedures performed to date) is approximately 0. 039% of the procedures and within the acceptable range as identified in risk analysis documentation.
Patient Sequence No: 1, Text Type: N, H10
[174695724]
Clinic reported a patient who developed swelling, redness and pain in axilla 18 days post miradry treatment. Antibiotics (bactrim) and steroids were prescribed. However, the symptoms worsen. Another set of antibiotics (keflex) was prescribed with steroids. The pain improved but swelling remained. Eventually, the redness resolved. By 17 days post-treatment, the affected area became discolored and began to peel. Patient did not have signs of a fever. Clinic referred the patient to an urgent care/er for further treatment but the patient declined.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008082710-2020-00001 |
| MDR Report Key | 9567100 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-08 |
| Date of Report | 2019-12-10 |
| Date of Event | 2019-11-22 |
| Date Mfgr Received | 2019-12-10 |
| Device Manufacturer Date | 2019-07-26 |
| Date Added to Maude | 2020-01-08 |
| 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 | 2020-01-08 |
| Model Number | MD4000-MC |
| Catalog Number | MD4000-MC |
| Lot Number | 19H1174 |
| Operator | HEALTH PROFESSIONAL |
| 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 | 2020-01-08 |