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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 04/29/2016
Event Type  Injury  
Manufacturer Narrative
Initial evaluation for reportability was listed as not reportable due to severity of injury. Upon further investigation it was determined that this may be classified as a serious injury and reportable.
 
Event Description
Consumer used product and reported that it burned her skin. Tried twice and it left blisters the second time.
 
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Brand NameILIGHT PRO PLUS QUARTZ
Type of DeviceIPL6000Q
Manufacturer (Section D)
SHASER INC
10 maguire road building 1
lexington MA 02421
Manufacturer (Section G)
SHASER INC
Manufacturer Contact
leticia booth
10 maguire road building 1
lexington, MA 02421
7819952255
MDR Report Key5988737
MDR Text Key55989750
Report Number3005855240-2016-00003
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
Type of Report Initial
Report Date 09/30/2016,09/29/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/29/2016
Is this an Adverse Event Report? Yes
Device Operator
Device Model NumberIPL6000Q
Device Catalogue NumberIPL6000Q
Device Lot Number11
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/30/2016
Distributor Facility Aware Date04/29/2016
Device Age11 MO
Event Location Home
Date Report to Manufacturer09/30/2016
Date Manufacturer Received04/29/2016
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 Reuse

Patient Treatment Data
Date Received: 09/29/2016 Patient Sequence Number: 1
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