FDA Adverse Event
Injury
Summary report: N
MIRADRY SYSTEM
MDR report key: 20102808
·
Received August 29, 2024
Report
- Report Number
- 3008082710-2024-70014
- Event Type
- Injury
- Date Received
- August 29, 2024
- Date of Event
- July 1, 2024
- Report Date
- August 8, 2024
- Manufacturer
- MIRADRY INC.
- Product Code
- OUB
- PMA / PMN Number
- K1311162
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
PENDING DEVICE EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED.
Description of Event or Problem · 0
FEMALE PATIENT 2 WEEKS POST TREATMENT DATE DEVELOPED ABSCESSES ON EACH UNDERARM. THE DOCTOR TREATED THEM WITH ANTIBIOTICS AND ANTI-INFLAMMATORY WHICH IMPROVED THE PATIENT'S CONDITION. THE PATIENT'S ABSCESSES HAVE FULLY RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1315441 | MIRADRY SYSTEM | MICROWAVE DERMATOLOGIC SYSTEM | OUB | MIRADRY INC. | MN-MD4000-MC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |