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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC ILIGHT PRO PLUS QUARTZ IPL6000Q

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SHASER INC ILIGHT PRO PLUS QUARTZ IPL6000Q Back to Search Results
Model Number IPL6000Q
Device Problem 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 10/03/2016
Event Type  Injury  
Event Description
Consumer claims unit gave her burn marks on her legs.
 
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Brand NameILIGHT PRO PLUS QUARTZ
Type of DeviceIPL6000Q
Manufacturer (Section D)
SHASER INC
81 hartwell ave
lexington MA 02421
Manufacturer Contact
leticia booth
81 hartwell ave
lexington, MA 02421
7819953528
MDR Report Key6074454
MDR Text Key59006877
Report Number3005855240-2016-00006
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
Type of Report Initial
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/02/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberIPL6000Q
Device Catalogue NumberIPL6000Q
Device Lot Number15102501273V
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/05/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/03/2016
Device Age1 YR
Event Location Home
Date Manufacturer Received10/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/25/2015
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: 11/02/2016 Patient Sequence Number: 1
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