MAUDE Adverse Event Report: ALMA LASERS LTD CO2 LASER; MEDICAL LASER

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/02/2018
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).Section h3: alma inc.(importer) has inspected the device and found the unit to be working within the manufacturer's specifications.(b)(4) has made multiple attempts to collect pertinent information, however, the facility has not responded to these requests.Alma ltd.Clinical reviewed limited information and could not determine if it is a serious injury.Given the lack of details, alma 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
As per the facility, the patient sustained slight burns on the external labia.

• Brand Name: CO2 LASER
• 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: 8460606
• Report Number: 3004167969-2019-00010
• Device Sequence Number: 16888527
• Product Code: GEX
• UDI-Device Identifier: 17290110120952
• UDI-Public: 17290110120952
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K103501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2019

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 02/26/2019
• Device Age: 1 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/28/2019
• 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