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

Model Number	DYE VL
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Codes	Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	02/08/2018
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) evaluated the device and found that energy output was below the specifications.As per alma ltd.Clinical, this finding is not likely to contribute to the adverse event.Based on the initial photos and information provided by the facility, alma ltd.Clinical concluded that given the patient's dark skin, the combination of excessive fluence and suboptimal cooling on the skin before and after the treatment is the most likely root cause for this untoward skin reaction.The independent medical expert contacted by alma ltd found the injury to be reversible first-degree burns.Due to non-permanent nature of the injury, the event was deemed non-reportable at that time.(b)(4).Made multiple follow up attempts for patient's condition and the facility noted a positive response.However, on 08/18/2018, (b)(4).Received patient follow up photos from the facility.These were forwarded to alma ltd.For re-assessment.Upon review of the photos, alma ltd clinical concluded that patient still has hypopigmentation areas and per company reportability criteria this should be reported to the fda.
Event or Problem Description
The suspected device was used on patient's thighs bilaterally for leg veins.The facility diagnosed the injury 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: 7870367
• Report Number: 3004167969-2018-00009
• Device Sequence Number: 19351759
• Product Code: GEX
• UDI-Device Identifier: 17290110120327
• UDI-Public: 17290110120327
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/18/2018

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: DYE VL
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2018
• Device Age: 5 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/12/2018
• 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: Disability