MAUDE Adverse Event Report: ALMA LASERS LTD HARMONY XL; POWERED LASER SURGICAL INSTRUMENT

Model Number	Q SWITCH 1064
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	10/20/2017
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).Alma lasers investigated the reported issue.On 11/09/2017, medical expert contacted by alma lasers stated photographs provided by the facility are of poor resolution.Expert presumes that patient's semi-permanent tattoo was composed of ferrous oxide and titanium oxide.Laser treatment on this area caused the oxidation and blackness (discoloration).The recommended treatment for such an allergic reaction is 6 to 10 treatments with q-switch ruby or yag.As per alma lasers ltd.Chief scientist officer, facility reported treatment parameters were within range.Upon assessing the given scenario, it appears that patient suffered laser induced permanent makeup allergic skin reaction.This is a well known adverse reaction in such cases and thus permanent makeup area should have been avoided.Alma lasers performed a patient follow up on 11/14/2017, facility informed that there has been no change in the discoloration on patient's forehead.Patient saw a permanent make up consultant and was advised that it needs to be recolored.Permanent make up is considered a tattoo and laser use on such area should be proceeded with caution.Clinician should have used better judgement in treating the patient.Based on experts evaluation, at this point, it seems user's (clinician) error in judgement is the likely cause of this adverse event.A letter will be sent to the customer to emphasize on known adverse reactions with these treatments.Since the device is not the suspected root cause of this event, it was not evaluated.Alma is submitting this in good faith efforts.Should additional information becomes available alma lasers ltd.Would submit supplemental report to fda within the published time lines for such reporting.
Event or Problem Description
The suspected device was used on skin type ii patient for resurfacing procedure on her forehead.Patient has a history of permanent makeup on her forehead.Permanent makeup is tan in color to cover hypopigmentation.According to the facility, few days after the q-switch treatment, permanent make up turned blue.Facility nurse diagnosed the condition as blue streaks on patient's forehead.

• Brand Name: HARMONY XL
• Common Device Name: POWERED LASER SURGICAL INSTRUMENT
• Manufacturer (Section D): ALMA LASERS LTD; 14 & 15 halamish st., pob 3021; caesarea north industrial park; caesarea hazafon, 30889 00; IS 3088900
• MDR Report Key: 7045880
• Report Number: 3004167969-2017-00004
• Device Sequence Number: 16480150
• Product Code: GEX
• UDI-Device Identifier: 17290110120525
• UDI-Public: 17290110120525
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 10/23/2017

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: Nurse
• Device Model Number: Q SWITCH 1064
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2017
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/26/2017
• Initial Report FDA Received Date: 11/20/2017
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 57 YR