MAUDE Adverse Event Report: ALMA LASERS 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	11/01/2018
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 inc.Made multiple attempts to request patient photographs and clarification on adverse event information, however, no response has been received.Alma ltd.Clinical reviewed the information and determined that the lack of skin test and the combination of high fluence and pulses may have caused excessive skin heat.However, in the absence of visual evidence and pertinent clinical information, at this time, no exact root cause can be determined.In good faith efforts, alma is submitting the report to the fda at this time.Supplemental report(s) will be submitted within the fda published timelines if any additional information becomes available.
Event or Problem Description
The suspected device was used on the patient's suprapubic area in linear appearance for hair removal.As per the facility, after the treatment, bikini burns appeared that night which scabbed eventually.The facility saw the patient again after a month and reported that the patient had hypopigmentation.

• Brand Name: SOPRANO 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: 8323564
• Report Number: 3004167969-2019-00007
• Device Sequence Number: 16486625
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/10/2019

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
• Device Model Number: 810
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 01/10/2019
• Device Age: 3 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/08/2019
• 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: Other
• Patient Age: 29 YR