MAUDE Adverse Event Report: BOSIDI TECHNOLOGY, CO., LTD. BOSIDIN FACIAL & BODY PERMANENT HAIR REMOVAL FOR WOMEN; LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL

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

Patient Problems Pain (1994); Burn, Thermal (2530)

Event Date 02/16/2019

Event Type  Injury  

Event Description

I tried to use the product that i bought from (b)(6).The link is (b)(6).However, after i used this device on my face, it felt very painful and my neck was burned up.When we tried to search fda info about this device, there is nothing.Is this product fda approved? the device was bought from (b)(6).

• Brand Name: BOSIDIN FACIAL & BODY PERMANENT HAIR REMOVAL FOR WOMEN
• Type of Device: LIGHT BASED OVER-THE-COUNTER HAIR REMOVAL
• Manufacturer (Section D): BOSIDI TECHNOLOGY, CO., LTD.
• MDR Report Key: 8470770
• MDR Text Key: 140603930
• Report Number: MW5085427
• Device Sequence Number: 1
• Product Code: OHT
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 28 YR