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

Model Number	1064NM (ND:YAG) MODULE
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Exemption letter e2013012 alma ltd.(manufacturer) is submitting this report on behalf of alma inc.(importer).Alma lasers has requested the customer to send the suspected device for evaluation and has also provided them the ups return label.Device evaluation will be performed once the device is returned to alma lasers.However an assessment of worldwide adverse incidents for the substantially similar devices was performed to determine whether the alleged injury is attributable to the device.No other similar incidents were noted and the company believes this is a singular incident.In all good faith efforts alma lasers is reporting this incident to the fda.Should any additional information becomes available, alma lasers ltd will file a follow-up report within time lines published by the fda.Based on the injury report, treatment parameters were evaluated and determined to be within recommended range(upper limit).However it was noted that the patient underwent 13 treatments which is excessive compared to alma lasers recommendation of 4 to 6 treatment sessions.This excessive number of treatments may explain the root cause of this adverse reaction.Though there is no information available on how the procedure was done but it is also possible that a small section was over treated leading to excessive energy accumulation that could have reached the deeper skin layer.A letter to the facility will be sent to emphasize on following the manufacturer's recommendations.On (b)(6) 2017 the clinical expert contacted by alma lasers diagnosed this dent as possible lipoatrophy based on available photographs.This is permanent and may require dermal filler.Alma lasers attempted multiple follow-ups on the patient's condition.As per the follow-up performed on (b)(6) 2017, the customer reported that the patient is getting better however no additional photographs were made available for an expert's assessment.In lack of additional photos, even when the patient is getting better alma lasers cannot determine if the injury is permanent or not.The patient is scheduled to return to the customer's facility next week.Alma lasers has requested additional photographs for the purpose of further medical assessment during this visit.In all good faith efforts alma lasers is reporting this incident to the fda.Should any additional information becomes available, alma lasers ltd will file a follow-up report within time lines published by the fda.
Event or Problem Description
The suspected device was used on skin type iii patient for skin resurfacing procedure on face.The patient alleged that her skin was dented on the left side of her face(lower cheek area) after the last treatment.Based on the facility notes the patient underwent 13 treatments with this suspected device.

• 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, ha zafon 30889 00; IS 3088900
• MDR Report Key: 6983454
• Report Number: 3004167969-2017-00002
• Device Sequence Number: 1196717
• Product Code: GEX
• UDI-Device Identifier: 17290110120525
• UDI-Public: 17290110120525
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072564
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/29/2017

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: Other
• Device Model Number: 1064NM (ND:YAG) MODULE
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/29/2017
• Device Age: 6 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2017
• Initial Report FDA Received Date: 10/27/2017
• 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: 42 YR