FDA Adverse Event
Injury
Summary report: N
MIRADRY SYSTEM
MDR report key: 3838748
·
Received May 29, 2014
Report
- Report Number
- 3008082710-2014-00005
- Event Type
- Injury
- Date Received
- May 29, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 21, 2014
- Manufacturer
- MIRAMAR LABS, INC.
- Product Code
- OUB
- PMA / PMN Number
- K103014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL SERIAL NUMBER ((B)(4)); ADDITIONAL LOT NUMBER (12H0306). REVIEW OF LOT HISTORY RECORDS FOR THE INVOLVED DEVICES CONFIRMED MANUFACTURING STEPS AND PROCESSES (INCLUDING STERILIZATION PROCESSING) WERE MET AND FOLLOWED, WITH NO ISSUES IDENTIFIED.
Description of Event or Problem · 1
THE PATIENT HAD HIS SECOND MIRADRY TREATMENT ON (B)(6) 2014. HE SHAVED HIS UNDERARMS THAT DAY WITH A STRAIGHT EDGE RAZOR ON DRY SKIN. ON (B)(6) 2014, THE PATIENT WAS SEEN BY A PLASTIC SURGEON AND AN INFECTION WAS DIAGNOSED. THE WOUND WAS PACKED AND AN ANTIBIOTIC WAS PRESCRIBED. ON (B)(6) 2014, A SECOND ANTIBIOTIC WAS PRESCRIBED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 316945 | MIRADRY SYSTEM | OUB | MIRAMAR LABS, INC. | MD4000-MC | 12H0472 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |