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

Model Number DYE VL

Device Problem Output below Specifications (3004)

Patient Problems Skin Discoloration (2074); Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)

Event Date 02/08/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4).(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 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
• Type of Device: MEDICAL LASER
• Manufacturer (Section D): ALMA LASERS LTD; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• Manufacturer Contact: ariela albalak ; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• MDR Report Key: 7870367
• MDR Text Key: 120006829
• Report Number: 3004167969-2018-00009
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290110120327
• UDI-Public: 17290110120327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DYE VL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/18/2018
• Device Age: 5 YR
• Date Manufacturer Received: 08/20/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability