MAUDE Adverse Event Report: ALMA LASER LTD SOPRANO XL; MEDICAL LASER

Model Number	810
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); Skin Discoloration (2074)
Date of Event	12/11/2018
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 it appears that unit may have been dropped or hit.The output was found to be within the manufacturer's specifications but the thermoelectric coupling (tec) was non-operational.Alma lasers made multiple attempts to request patient photographs and pertinent adverse event information.The facility did not provide the adverse event details until the day before the reportability 30-day deadline.Alma lasers (b)(4) clinical reviewed the information and found some of the pertinent information to be lacking.Alma lasers (b)(4).Clinical determined that vital information on past treatment records need to be explored.In the absence of visual evidence and pertinent clinical information, at this time, no root cause can be assessed.However, in good faith efforts, alma lasers is submitting the report to the fda at this time.Alma lasers is investigating this issue and will submit supplemental reports within the fda published timelines if additional information becomes available.
Event or Problem Description
The suspected device was used on the patient's anterior entire legs and right inner thigh for unwanted hair.As per the facility, patient sustained burns up and down the legs with scabbing.The right inner thigh area had broken skin.The burns appeared in the evening after treatment.The facility provided patient with neosporin to apply to all areas with light dressings.As per the facility, the patient has on-going pigmentation.

• Brand Name: SOPRANO XL
• Common Device Name: MEDICAL LASER
• Manufacturer (Section D): ALMA LASER LTD; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• MDR Report Key: 8242543
• Report Number: 3004167969-2019-00004
• Device Sequence Number: 11332705
• Product Code: GEX
• UDI-Device Identifier: 17290110120662
• UDI-Public: 17290110120662
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083848
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 12/13/2018

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: 810
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/13/2018
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2019
• Initial Report FDA Received Date: 01/11/2019
• 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: 26 YR