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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC ILIGHT ULTRA FACE AND BODY IPL6500

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SHASER INC ILIGHT ULTRA FACE AND BODY IPL6500 Back to Search Results
Model Number IPL6500
Device Problems Application Program Problem: Parameter Calculation Error (1449); Incorrect Software Programming Calculations (1495); Programming Issue (3014)
Patient Problems Burn(s) (1757); Burn, Thermal (2530); Partial thickness (Second Degree) Burn (2694)
Event Date 09/19/2016
Event Type  Injury  
Event Description
Customer got blisters to the skin the day after treatment.
 
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Brand NameILIGHT ULTRA FACE AND BODY
Type of DeviceIPL6500
Manufacturer (Section D)
SHASER INC
81 hartwell ave
lexington MA 02421
Manufacturer Contact
leticia booth
81 hartwell ave
lexington, MA 02421
7819953528
MDR Report Key6063465
MDR Text Key58637140
Report Number3005855240-2016-00004
Device Sequence Number1
Product Code ONF
Combination Product (y/n)N
Reporter Country CodeBU
PMA/PMN Number
141583
Number of Events Reported1
Summary Report (Y/N)N
Report Source Distributor
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPL6500
Device Catalogue NumberIPL6500
Device Lot Number26
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date09/19/2016
Device Age10 MO
Event Location Home
Date Manufacturer Received09/19/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/28/2016 Patient Sequence Number: 1
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