MAUDE Adverse Event Report: ALMA LASERS LTD ACCENT; MEDICAL LASER

Model Number	RF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694)
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.Alma ltd.Clinical reached out to an independent medical expert for the medical assessment.As per their assessment, the patient may have had deep second degree burns.(b)(4) has made multiple attempts to request patient follow-up condition; no updates are available.Alma ltd.Clinical has therefore, determined this event to be reportable and is submitting this report to the fda in good faith efforts.Should any information become available, alma will submit supplemental report within the fda published timelines.
Event or Problem Description
The suspected device was used on the patient's abdomen.As per the facility, the patient reported she has sustained a small burn 1 inch to the right of her belly button.The patient called in to report this burn two weeks after the treatment.

• Brand Name: ACCENT
• 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: 8404853
• Report Number: 3004167969-2019-00009
• Device Sequence Number: 389672
• Product Code: IMI
• UDI-Device Identifier: 17290110120228
• UDI-Public: 17290110120228
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160075
• 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): 02/06/2019

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: RF
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 02/06/2019
• Device Age: 7 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2019
• Initial Report FDA Received Date: 03/08/2019
• 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: Disability
• Patient Age: 53 YR