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

Model Number	Q SWITCH
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	01/22/2019
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 made an attempt for device retrieval and is in the process of making further attempts to request the device back for evaluation.On latest device retrieval attempt, the facility stated that they did not have any other incidents with this device.Alma ltd.Clinical reached out to an independent medical expert for formal medical assessment.As per their assessment, the patient may have had an allergic reaction to one of the tattoo component.Alma ltd.Clinical reviewed the information and determined that although parameters are within range, the pulse rate with energy settings may have caused the overlapping.This may have resulted in excessive heat leading to the untoward skin reaction.As per the recent follow-up, the facility has not noticed any evidence of hyper or hypo pigmentation, and the patient is healing.Alma ltd.Clinical has reviewed the follow-up information and determined this event to be reportable due to patient's claim of visiting the er, and is submitting this report to the fda in good faith efforts.Should any information become available, alma will submit supplemental report(s) within the fda published timelines.
Event or Problem Description
The suspected device was used on the patient's right leg (ankle to calf) for tattoo removal.The facility reported severe pain, blistering and swelling.As per the facility, they advised the patient not to pick at any scabs or blisters, and to keep the area clean and moisturized.Later, the patient admitted to the facility that he drained his blisters and wears steel toe boots at work.The patient was requested to come in for evaluation by the facility doctor, however, he went to the er.According to the facility, the medication being used is ibuprofen.The facility stated they followed up with the patient but he has refused to cooperate and does not follow instructions.

• 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: 8362654
• Report Number: 3004167969-2019-00008
• Device Sequence Number: 13933478
• Product Code: GEX
• UDI-Device Identifier: 17290110120525
• UDI-Public: 17290110120525
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 01/23/2019

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?: No
• Distributor Facility Aware Date: 01/23/2019
• Device Age: 7 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/22/2019
• 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: Other
• Patient Age: 50 YR