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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC ILIGHT IPL6500

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SHASER INC ILIGHT IPL6500 Back to Search Results
Model Number IPL6500
Device Problems Use of Device Problem (1670); Insufficient Information (3190)
Patient Problems Eye Injury (1845); Retinal Injury (2048)
Event Date 04/15/2019
Event Type  Injury  
Manufacturer Narrative
The device in question was not returned so we were unable to conduct an investigation of it. However, the dhr of the device from the supplier showed that all items met the design specifications when shipped from the manufacturer. Moreover: the ipl6500 device is designed and manufactured with a specific cap meant to be used on the female face below the cheekbone. This facial attachment was designed with no vent holes to minimize the light leakage when operating below the cheekbone. In addition, the device has skin contact sensors that prevent accidental flashing. The device will not flash unless both of the skin contact sensors are in full contact with the skin. The instructions for use of the device show and warn the user multiple times how to properly use the facial attachment. This is covered in the skin chart section, the warnings and safety section, the treatment section, and the faq section. The instructions for use specifically warn that using the device on or around the eyes, eyebrows, or eyelashes can cause serious and permanent eye injury. This is the only complaint of this nature that spectrum brands, inc. Owner of shaser,inc has received in the 5 years we have sold the device. Spectrum brands, inc. Owner of shaser, inc. Received this complaint from a previously unknown end-user located in (b)(6). Neither spectrum nor shaser sell this device in (b)(6) and currently suspect that this activity may have occurred through an unauthorized third-party distribution channel or a counterfeiter. Spectrum filed initial voluntary self-disclosure notices regarding this issue with the u. S. Treasury department¿s office of foreign assets control (ofac) and u. S. Commerce department¿s bureau of industry & security (bis) on june 20, 2019 and will provide complete reports to those agencies regarding potential economic sanctions or export control concerns within 60 days.
 
Event Description
The end user reported using the ipl6500 and the device caused an injury to her eyes.
 
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Brand NameILIGHT IPL6500
Type of DeviceIPL6500
Manufacturer (Section D)
SHASER INC
3001 deming way
middleton WI 53562
Manufacturer (Section G)
SHASER INC
Manufacturer Contact
lavee yang
3001 deming way
middleton, WI 53562
6082786362
MDR Report Key8737821
MDR Text Key149336484
Report Number3005855240-2019-00001
Device Sequence Number1
Product Code ONF
Combination Product (y/n)Y
Reporter Country CodeIR
PMA/PMN Number
K120080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 06/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/26/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberIPL6500
Device Catalogue NumberIPL6500
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/26/2019
Event Location Home
Date Report to Manufacturer06/26/2019
Date Manufacturer Received05/29/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/26/2019 Patient Sequence Number: 1
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