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

Model Number	DYE - VL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	08/13/2015
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 evaluated the device and found that it meets manufacturer's specifications.(importer) has evaluated the device and found that it meets manufacturer's specifications.In 2015, based on the available photographs, an independent clinical expert evaluated the injury to be reversible skin damage and the incident was determined to be not reportable.On 10/30/2018, (b)(4) received additional information that captures patient injury notes from the dermatologist she visited.There are no recent photos available to determine any existing permanent damage.Alma ltd.Clinical re-evaluated the alleged incident to be reportable and is submitting this report in good faith efforts.As evaluated in 2015, the most likely root cause is the patient's recent skin tanning prior to the procedure.
Event or Problem Description
The suspected device was used on the patient's chest for lesions at (b)(6) clinic in (b)(6).

• 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: 8112496
• Report Number: 3004167969-2018-00011
• Device Sequence Number: 1721903
• Product Code: GEX
• UDI-Device Identifier: 17290110120327
• UDI-Public: 17290110120327
• Combination Product (Y/N): N
• 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): 10/30/2018

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: 10/30/2018
• Device Age: 5 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/31/2018
• Initial Report FDA Received Date: 11/28/2018
• 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
• Patient Age: 46 YR