MAUDE Adverse Event Report: MIRAMAR LABS, INC. MIRADRY SYSTEM; MICROWAVE DERMATOLOGIC SYSTEM

Model Number MD4000-MC

Device Problem Use of Device Problem (1670)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/14/2015

Event Type  Injury  

Manufacturer Narrative

Although burns and ulcerations are known rare risks of the procedure, investigation revealed the clinic was not using a water-based lubricant as specified in the instructions for use.The clinic was using a laser coupling gel (which is not a lubricant).Use of less viscous lubricants (and in this case a much thicker gel) will create a barrier between the device and skin, affecting the ability of the device to cool the skin.It is believed this contributed to the injury.User manual has been updated to be clearer regarding validated lubricants.Field correction in process.Review of lot history records for the involved device confirmed manufacturing steps and processes were met and followed.There have been no issues with any sterile disposable manufacturing lots produced to date.Product met specifications prior to shipment.

Event Description

Patient experienced multiple small blisters / burns on her left underarm only after procedure.The physician had difficulty with suction on that arm during the procedure.Recently found out the physician prescribed antibiotic to heal.Patient was referred to another physician for treatment; no further information on outcome is available.

• Brand Name: MIRADRY SYSTEM
• Type of Device: MICROWAVE DERMATOLOGIC SYSTEM
• Manufacturer (Section D): MIRAMAR LABS, INC.; 2790 walsh ave.; santa clara CA 95051
• Manufacturer (Section G): MIRAMAR LABS, INC.; 2790 walsh ave.; santa clara CA 95051
• Manufacturer Contact: kathy o'shaughnessy ; 2790 walsh ave.; santa clara, CA 95051 ; 4089408700
• MDR Report Key: 5170517
• MDR Text Key: 29024950
• Report Number: 3008082710-2015-00039
• Device Sequence Number: 1
• Product Code: OUB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K131162
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MD4000-MC
• Device Catalogue Number: MD4000-MC
• Device Lot Number: 14H0213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 37 YR
• Patient Weight: 58