MAUDE Adverse Event Report: SHASER INC REMINGTON I-LIGHT HAIR REMOVAL SYSTEM; LUMENA

Model Number IPL6780

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

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 03/04/2021

Event Type  Injury  

Manufacturer Narrative

The ipl6780 is not marketed for sale in the us and therefore not listed with fda.The model is however similar in design and function as the ipl6800 which is listed under 510k number k140631.

Event Description

Consumer reported that after using the device, she developed blisters on her foot and calf that required medical treatment.Dr recommended granuflex dressing.

• Brand Name: REMINGTON I-LIGHT HAIR REMOVAL SYSTEM
• Type of Device: LUMENA
• Manufacturer (Section D): SHASER INC; 3001 deming way; middleton WI 53562
• Manufacturer Contact: tom baumgard ; 3001 deming way; middleton, WI 53562 ; 608275-449
• MDR Report Key: 11867106
• MDR Text Key: 259680501
• Report Number: 3005855240-2021-00001
• Device Sequence Number: 1
• Product Code: ONF
• Combination Product (y/n): Y
• Reporter Country Code: PL
• PMA/PMN Number: K140631
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: IPL6780
• Device Catalogue Number: IPL6780
• Device Lot Number: 19112902829V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2021
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/17/2021
• Distributor Facility Aware Date: 04/19/2021
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 05/17/2021
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/29/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 30 YR
• Patient Weight: 78