MAUDE Adverse Event Report: SHASER, INC. ILIGHT IPL6750

Model Number IPL6750

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)

Event Date 04/24/2017

Event Type  Injury  

Event Description

A consumer from (b)(6) region reported a burn injury when using model# ipl6750 and returned the device to the shop.

• Brand Name: ILIGHT IPL6750
• Type of Device: IPL6750
• Manufacturer (Section D): SHASER, INC.; 8123 forsythia street; suite 120; middleton WI 53562
• Manufacturer (Section G): SHASER, INC.
• Manufacturer Contact: lavee yang ; 8123 forsythia st; suite 120; middleton, WI 53562 ; 6082786362
• MDR Report Key: 7887204
• MDR Text Key: 120690120
• Report Number: 3005855240-2018-00001
• Device Sequence Number: 1
• Product Code: ONF
• Combination Product (y/n): Y
• Reporter Country Code: HR
• PMA/PMN Number: K120080
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/23/2017,07/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IPL6750
• Device Catalogue Number: IPL6750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/23/2017
• Distributor Facility Aware Date: 07/19/2017
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 07/23/2017
• Date Manufacturer Received: 07/19/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Weight: 64