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 Code	Burn(s) (1757)
Date of Event	05/24/2017
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.It was found that the device energy output was below specifications.Alma inc.Was recently made aware of an incident that "ocurred" in 2017 through a third-party.(b)(4) made multiple attempts to obtain information about the alleged incident from the facility, however, received no response.In "absense" of any information, (b)(4).Regulatory advised to perform another follow-up in case any additional details become available.On 11/01/2018, (b)(4) received additional information from a third party.After the review, (b)(4) clinical concluded that given the information pertaining to patient's skin condition even after 90 days, the event is to be reported in compliance with the company's protocol and in good faith.In the absence of pertinent clinical parameters and photographs, (b)(4) clinical cannot fully ascertain the root cause.
Event or Problem Description
The suspected device was used on patient's chest and shoulders.

• 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: 8069917
• Report Number: 3004167969-2018-00010
• Device Sequence Number: 13984684
• Product Code: GEX
• UDI-Device Identifier: 17290110120327
• UDI-Public: 17290110120327
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/20/2018

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: 08/20/2018
• Device Age: 4 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 11/14/2018
• 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: 38 YR