MAUDE Adverse Event Report: NOOD FLASHER 2.0 IPL HAIR REMOVAL DEVICE; POWERED LASER SURGICAL INSTRUMENT

Model Number KCA423

Device Problems Protective Measures Problem (3015); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Date 04/19/2023

Event Type  Injury  

Event Description

The nood flasher 2.0 device intermittently leaks electric current into the activation button during the flash discharge operation, causing a user to feel a high voltage electric jolt during use.The jolt is enough to either let go of the device or cause severe distress to the finger/hand.

• Brand Name: FLASHER 2.0 IPL HAIR REMOVAL DEVICE
• Type of Device: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): NOOD; 1109 e 5th st.; austin TX 78702
• MDR Report Key: 16809925
• MDR Text Key: 314028635
• Report Number: MW5117024
• Device Sequence Number: 1
• Product Code: GEX
• 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: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: KCA423
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian