MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL; MEDICAL LASER

Model Number	SHR PRO
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074)
Date of Event	01/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption letter e2013012 alma ltd.(manufacturer) is submitting the report on behalf of alma, inc.(importer).Section h3: alma inc.(importer) has made multiple attempts to request device back for inspection, however, no response has been received.Based on the information provided by the facility, alma ltd.Clinical determined that lack of skin test prior to the treatment and treatment area being left unprotected potentially made it prone to pulsed light energy absorption.This may explain the untoward skin reaction i.E.Burn.Alma inc.Performed a follow up to inquire about the patient's condition.As per the facility, the area has healed completely, but the tattoo in that spot is ruined.Alma ltd.Clinical evaluated the follow-up photograph but at this time alma cannot fully determine if the injury has resolved completely and therefore, submitting the report to the fda in good faith efforts.
Event or Problem Description
The suspected device was used on the patient's left shoulder blade for hair removal.As per the facility, the area was not covered with anything and after treatment, the skin around the tattoo became red and inflamed almost like a burn.The patient complained that it was painful.After few hours, the redness and tenderness disappeared.Few days later, facility noticed scabs on the tattoo and that the skin on pigment was peeling.According to the facility notes, this injury was diagnosed as a burn.

• Brand Name: HARMONY XL
• Common Device Name: MEDICAL LASER
• Manufacturer (Section D): ALMA LASERS LTD; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• MDR Report Key: 8317010
• Report Number: 3004167969-2019-00006
• Device Sequence Number: 13850417
• Product Code: GEX
• UDI-Device Identifier: 17290110120389
• UDI-Public: 17290110120389
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K072564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: SHR PRO
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/08/2019
• Device Age: 5 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR