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

Model Number	Q SWITCH 1064
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	07/18/2018
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).This was diagnosed as a case of q-switch induced chrysiasis caused due to residual intracellular gold received for rheumatoid arthritis.Therefore, device is not required to be tested.During investigation, the customer noted that the patient did not provide any gold therapy, rheumatoid arthritis and any related medication history on the treatment day.It is during the follow-up when patient indicated that she did get gold shots in the past.There is no corrective or preventive action as it is widely known that laser treatments should be avoided on patients with history of gold therapy.This is also covered in user training and operator's manual.This discoloration may be permanent and may require additional laser intervention.Therefore, alma lasers is reporting this to the fda.
Event or Problem Description
The suspected device was used on patient's forehead.As per the facility, six pulses were applied to the forehead.Patient indicated pain and purple hue developed.Treatment was suspended after the reaction was noted.

• 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: 7807145
• Report Number: 3004167969-2018-00007
• Device Sequence Number: 11172040
• Product Code: GEX
• UDI-Device Identifier: 17290110121379
• UDI-Public: 17290110121379
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 07/23/2018

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: Health Professional
• Device Model Number: Q SWITCH 1064
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 07/23/2018
• Device Age: 18 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 08/22/2018
• 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: 69 YR