GENTLEMAX PRO 9914-00-9035

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-26 for GENTLEMAX PRO 9914-00-9035 manufactured by Candela Corporation.

MAUDE Entry Details

Report Number1218402-2020-00021
MDR Report Key9885520
Report SourceUSER FACILITY
Date Received2020-03-26
Date of Report2020-03-26
Date of Event2020-01-30
Date Mfgr Received2020-03-06
Device Manufacturer Date2018-12-07
Date Added to Maude2020-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMRS. YVERRE BOBAY
Manufacturer Street530 BOSTON POST ROAD
Manufacturer CityWAYLAND, MA
Manufacturer CountryUS
Manufacturer Phone3580304
Manufacturer G1CANDELA CORPORATION
Manufacturer Street530 BOSTON POST ROAD
Manufacturer CityWAYLAND, MA
Manufacturer CountryUS
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGENTLEMAX PRO
Generic NameGENTLEMAX PRO
Product CodeGEX
Date Received2020-03-26
Model Number9914-00-9035
Device AvailabilityY
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerCANDELA CORPORATION
Manufacturer Address530 BOSTON POST ROAD WAYLAND, MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2020-03-26

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