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 2020-01-09 for MIRADRY SYSTEM MD4000-MC-EU manufactured by Miradry, Inc..
[174458523]
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. Analysis of treatment data recorded by the system revealed nothing unusual. There were no device performance observed that would cause the symptom. It is suspected that the clinic performed double-pass treatment or treated the skin twice in one session, which is not recommended as specified during training and in the user manual. Double-pass treatment may increase the likelihood of adverse events to occur such as burns or blisters. Also, it is suspected that the clinic did not use miradry's recommended volume of anesthesia. The high volume of anesthesia or hva method increases the volume of fluid injected into the target tissue to create a separation between the skin and nerves which protects the underlying structures (e. G. Brachial plexus) and reduces the likelihood of nerve injuries. The rate of burns seen ((b)(4) reportable incidents out of estimated (b)(4) procedures performed to date) is approximately 0. 016% of the procedures and within the acceptable range as identified in risk analysis documentation.
Patient Sequence No: 1, Text Type: N, H10
[174458524]
Clinic reported a patient who developed a 3rd degree burn 4. 1 months post miradry treatment. Patient experienced parenthesis and pain on left upper arm. Sterile compression tape with antibiotic ointment (fucidine) were used to treat the symptoms.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3008082710-2020-00002 |
| MDR Report Key | 9572126 |
| Report Source | COMPANY REPRESENTATIVE,CONSUM |
| Date Received | 2020-01-09 |
| Date of Report | 2019-12-11 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-12-11 |
| Device Manufacturer Date | 2018-03-04 |
| Date Added to Maude | 2020-01-09 |
| 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 | 2020-01-09 |
| Model Number | MD4000-MC-EU |
| Catalog Number | MD4000-MC-EU |
| Lot Number | 18H2616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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. Other | 2020-01-09 |