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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHASER INC I-LIGHT PRO IPL6500

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SHASER INC I-LIGHT PRO IPL6500 Back to Search Results
Model Number IPL6500
Device Problems Use of Device Problem (1670); 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 07/21/2016
Event Type  Injury  
Event Description
Consumer used it when she received it, and then 2 weeks later as instructed. During this second use, she noticed a spot on the cap / head. She also noticed a burn mark on her leg, that appears to be related to the spot on the cap.
 
Event Description
Consumer used it when she received it, and then 2 weeks later as instructed. During this second use, she noticed a spot on the cap / head. She also noticed a burn mark on her leg, that appears to be related to the spot on the cap.
 
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Brand NameI-LIGHT PRO IPL6500
Type of DeviceIPL6500
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 Key5903365
MDR Text Key52966193
Report Number3005855240-2016-00002
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,Followup
Report Date 10/28/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2016
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberIPL6500
Device Catalogue NumberIPL6500
Device Lot Number13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/12/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/28/2016
Distributor Facility Aware Date07/21/2016
Device Age5 MO
Event Location Home
Date Report to Manufacturer10/28/2016
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
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: 08/25/2016 Patient Sequence Number: 1
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