FDA Adverse Event Injury Summary report: N

GENTLEMAX

MDR report key: 2452550 · Received February 10, 2012

Report

Report Number: 1218402-2012-00003
Event Type: Injury
Date Received: February 10, 2012
Date of Event: December 26, 2011
Report Date: February 10, 2012
Manufacturer: CANDELA CORP.
Product Code: GEX
PMA / PMN Number: K063074
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS INSTALLED AT THE USER SITE JANUARY 30, 2008. THERE HAS ONLY BEEN ONE CLINICAL COMPLAINT FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WERE REVIEWED 2/10/2012 WITH NO CONCLUSION MADE. A CANDELA CLINICAL MANAGER VISITED THE USER SITE AND CONCLUDED THAT THE FLUENCES AND DCD SETTINGS USED BY THE SITE WERE OUTSIDE THE RECOMMENDED CANDELA TREATMENT GUIDELINES. THE TREATMENT PARAMETERS REPORTEDLY USED BY THE OPERATOR WERE: 18 MM SPOT SIZE, 3 MS PULSE DURATION, 20-26 J/CM2, 40/20/0 OR 50/20/0 DCD SETTING, WHICH ARE NOT WITHIN THE TREATMENT PARAMETERS FOR SKIN TYPE V - VI. CUSTOMER AT USER SITE REPORTED THAT THEY HAD NO PREVIOUS TREATMENT ISSUES USING THESE SETTINGS. DESPITE THE RECOMMENDATION GIVEN BY THE CLINICAL MANAGER TO USE THE RECOMMENDED TREATMENT PARAMETERS, THE CUSTOMER CLAIMED THAT THE RECOMMENDED SETTINGS DO NOT WORK. BASED ON THIS INFO, THESE TREATMENT SETTINGS MAY HAVE BEEN CONTRIBUTING FACTORS TO THE BURNS.

Description of Event or Problem · 1

A SITE REPORTED THAT PTS WITH SKIN TYPES V - VI WHO RECEIVED HAIR REMOVAL TREATMENT RESPONDED WITH BURNS ON THE TREATED AREAS. THE SITE REPORTED THAT PTS REPORTED BURNS ONLY WHEN TREATED WITH THE 1064 NM LASER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	GENTLEMAX	DERMATOLOGY LASER	GEX	CANDELA CORP.	9914-00-0400	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other