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

Model Number	540 VL/PL
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Burn(s) (1757); Partial thickness (Second Degree) Burn (2694); Full thickness (Third Degree) Burn (2696)
Date of Event	11/08/2018
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).Alma inc.(importer) has evaluated the handpiece and found that it meets manufacturer's specifications.The system was also inspected and it was found that it had a damaged handpiece connector.The damaged handpiece connector is not likely to contribute to the adverse event as the system cannot be operated in this condition.It appears that the damage to the handpiece connector may have occurred during the transit back to alma.Per the facility, patient burns were diagnosed as second and third degree burns.At this time no new photographs or information is available to assess the patient skin condition.Therefore, alma lasers is submitting the report to fda in good faith efforts.Based on the information available, alma lasers ltd.Clinical determined that failure to perform skin test and the number of pulses administered for the patient's skin condition were likely excessive contributing towards this untoward skin reaction.
Event or Problem Description
The suspected device was used on patient's legs bilaterally for benign pigmented lesions.The facility provided the patient with biafine topical emulsion and 800 mg ibuprofen as post-treatment care.Per the facility, the patient was seeing a wound care specialist as an out-patient initially but was later admitted as an in-patient.

• Brand Name: HARMONY
• 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: 8152571
• Report Number: 3004167969-2018-00012
• Device Sequence Number: 10830044
• Product Code: GEX
• UDI-Device Identifier: 17290110120433
• UDI-Public: 17290110120433
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K072564
• 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): 11/12/2018

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: 540 VL/PL
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 11/12/2018
• Device Age: 7 YR
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: Hospitalization
• Patient Age: 45 YR