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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC I-LIGHT PRO IPL6000

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SHASER INC I-LIGHT PRO IPL6000 Back to Search Results
Model Number IPL6000
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 09/20/2016
Event Type  Injury  
Event Description
Consumer experienced burns on leg after using device. Device had previously been used with no issue. Testing was completed on returned unit and the energy-level of the flash output was profiled with the original and test replacement cartridges. There was no observed deviance from the product performance specification.
 
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Brand NameI-LIGHT PRO
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 Key6064174
MDR Text Key58658176
Report Number3005855240-2016-00005
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 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2016
Device Operator
Device Model NumberIPL6000
Device Catalogue NumberIPL6000
Device Lot Number40
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2016
Distributor Facility Aware Date09/29/2016
Device Age1 YR
Event Location Home
Date Report to Manufacturer10/28/2016
Date Manufacturer Received10/04/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/16/2015
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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