MAUDE Adverse Event Report: ERCHONIA CORPORATION ZERONA ; FAT REDUCING LOW LEVEL LASER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cancer (3262)

Event Date 01/21/2020

Event Type  Injury  

Event Description

Cancer; i received zerona therapy (makes holes in fat cells) in one particular area under my arm pit / near my breast in 2014 and now 6 years later i have breast cancer in that exact same location (i'm (b)(6) y/o) and feel there is a link as i have no family history.Fda safety report id# (b)(4).

• Brand Name: ZERONA
• Type of Device: FAT REDUCING LOW LEVEL LASER
• Manufacturer (Section D): ERCHONIA CORPORATION
• MDR Report Key: 9800735
• MDR Text Key: 182738699
• Report Number: MW5093577
• Device Sequence Number: 1
• Product Code: OLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 41 YR