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

Model Number	Q SWITCH
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Skin Discoloration (2074); Partial thickness (Second Degree) Burn (2694)
Date of Event	02/05/2018
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 output met the specifications.Based on the initial photos and information provided by the facility, alma clinical concluded that the combination of high energy and high repetition rate is the root cause for this untoward skin reaction.The independent medical expert contacted by alma determined the injury to be reversible second degree burns.Based on the non-permanent nature of the injury, the alleged event was deemed non-reportable.Alma made multiple attempts to request the facility for an update on patient condition.On (b)(6) 2018 the facility finally updated alma that the hyperpigmentation from tattoo removal has not improved at all.Alma clinical re-evaluated the incident based on additional information received and determined it to be reportable at this time.
Event or Problem Description
The suspected device (532 nm wavelength) was used on patient's ankle for tattoo removal.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: 7834462
• Report Number: 3004167969-2018-00008
• Device Sequence Number: 1703757
• Product Code: GEX
• UDI-Device Identifier: 17290110120525
• UDI-Public: 17290110120525
• 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): 08/02/2018

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: Q SWITCH
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/02/2018
• Device Age: 2 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/30/2018
• 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