MAUDE Adverse Event Report: SHASER INC ILIGHT PRO IPL6000

Model Number IPL6000

Device Problems Electrical /Electronic Property Problem (1198); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problems Burn(s) (1757); Burn, Thermal (2530)

Event Date 08/15/2014

Event Type  malfunction  

Event Description

Consumer complained that while using the product she was burned and has pain.

Event Description

Consumer complained that while using the product she was burned and has pain.

• Brand Name: ILIGHT PRO IPL6000
• Type of Device: IPL6000
• Manufacturer (Section D): SHASER INC; 81 hartwell ave; lexington MA 02421
• Manufacturer (Section G): SHASER INC
• Manufacturer Contact: leticia booth ; 81 hartwell ave; lexington, MA 02421 ; 7819953528
• MDR Report Key: 5669917
• MDR Text Key: 46698834
• Report Number: 3005855240-2016-00001
• Device Sequence Number: 1
• Product Code: ONF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: consumer
• Reporter Occupation: Patient
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 10/28/2016

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: Lay User/Patient
• Device Model Number: IPL6000
• Device Catalogue Number: IPL6000
• Device Lot Number: 12091700160V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/28/2016
• Distributor Facility Aware Date: 08/15/2014
• Device Age: 43 MO
• Event Location: Home
• Date Report to Manufacturer: 10/28/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other