ILIGHT PRO PLUS QUARTZ IPL6000Q

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-11-02 for ILIGHT PRO PLUS QUARTZ IPL6000Q manufactured by Shaser Inc.

MAUDE Entry Details

Report Number3005855240-2016-00006
MDR Report Key6074454
Date Received2016-11-02
Date of Report2016-10-31
Date of Event2016-10-03
Date Facility Aware2016-10-03
Date Mfgr Received2016-10-03
Device Manufacturer Date2015-10-25
Date Added to Maude2016-11-02
Event Key0
Report Source CodeDistributor report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. LETICIA BOOTH
Manufacturer Street81 HARTWELL AVE
Manufacturer CityLEXINGTON MA 02421
Manufacturer CountryUS
Manufacturer Postal02421
Manufacturer Phone7819953528
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameILIGHT PRO PLUS QUARTZ
Generic NameIPL6000Q
Product CodeONF
Date Received2016-11-02
Returned To Mfg2016-10-05
Model NumberIPL6000Q
Catalog NumberIPL6000Q
Lot Number15102501273V
ID NumberNI
OperatorLAY USER/PATIENT
Device AvailabilityR
Device Age1 YR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerSHASER INC
Manufacturer Address81 HARTWELL AVE LEXINGTON MA 02421 US 02421



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