FDA Adverse Event Injury Summary report: N

GENTLEMAX

MDR report key: 2236532 · Received August 31, 2011

Report

Report Number: 1218402-2011-00003
Event Type: Injury
Date Received: August 31, 2011
Date of Event: July 15, 2011
Report Date: August 31, 2011
Manufacturer: CANDELA CORP
Product Code: GEX
PMA / PMN Number: K063074
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE PRODUCT WAS INSTALLED AT THE USER SITE (B)(6), 2009. THERE HAVE BEEN NO CLINICAL COMPLAINTS FROM THE USER SITE REGARDING THIS SPECIFIC SERIAL NUMBER SINCE THAT TIME. THE PRODUCT DEVICE HISTORY RECORD AND SERVICE HISTORY WAS REVIEWED (B)(6) 2011 WITH NO CONCLUSIONS MADE.

Description of Event or Problem · 1

(B)(6) REPORTED TO CANDELA CORP ON (B)(6) 2011, THAT A MALE PT RECEIVED A LASER HAIR REMOVAL TREATMENT ON THE BIKINI/GROIN AREA AND REPORTED "BURNS" IN THE TREATED AREA; SPECIFICALLY ON THE PENIS SHAFT AND HEAD. (B)(6) STATED THAT THE PT RECEIVED THE LASER HAIR REMOVAL TREATMENT ON (B)(6) 2011 AND THAT TOPICAL ALOE VERA WAS IMMEDIATELY APPLIED TO THE TREATED AREA POST TREATMENT AS SUGGESTED PER CANDELA'S TREATMENT GUIDELINES. SHE THEN STATED THAT THE PT WENT ON A BUSINESS TRIP SOON AFTER THE TREATMENT, BUT HE DID NOT TELL THEM THAT HE HAD AN ADVERSE REACTION UNTIL (B)(6) 2011. THE PT WAS PRESCRIBED SILVADENE CREAM AND AFTER A COUPLE WEEKS OF USING THE SILVADENE, THE PT STATED THAT 90% OF THE INJURED AREA HAD HEALED ACCORDING TO (B)(6). HOWEVER, THE PT THEN WENT ON VACATION AND CALLED THEM BACK TO STATE THAT THE AREA WAS NOT HEALING AFTER HIS RETURN. (B)(6) ALSO STATED THAT THE PT WENT TO A LOCAL BURN CENTER FOR TREATMENT.

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			Required Intervention