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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC ILIGHT PRO IPL6000

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SHASER INC ILIGHT PRO IPL6000 Back to Search Results
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.
 
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Brand NameILIGHT PRO IPL6000
Type of DeviceIPL6000
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 Key5669917
MDR Text Key46698834
Report Number3005855240-2016-00001
Device Sequence Number1
Product Code ONF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K120080
Number of Events Reported1
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
Date FDA Received05/20/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPL6000
Device Catalogue NumberIPL6000
Device Lot Number12091700160V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2016
Distributor Facility Aware Date08/15/2014
Device Age43 MO
Event Location Home
Date Report to Manufacturer10/28/2016
Date Manufacturer Received08/15/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/17/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/20/2016 Patient Sequence Number: 1
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