MAUDE Adverse Event Report: ALMA LASERS LTD SOPRANO ICE; MEDICAL LASER

Model Number	810
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Superficial (First Degree) Burn (2685); Partial thickness (Second Degree) Burn (2694)
Date of Event	10/02/2018
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 it to be performing within the manufacturer specifications.Based on the information provided by the account, alma ltd.Chief scientist officer determined that given the patient skin type and multiple areas treated, conducting a skin test prior to the treatment could have prevented this untoward skin reaction.Alma approached an independent medical expert for a formal medical assessment.As per the assessment, the injury was reversible and therefore, this event was deemed to be non-reportable at the time.(b)(4) performed patient follow-ups to inquire about patient's condition.On 12/26/2018, the facility reported that the patient seems to be healing well but would require laser resurfacing to correct scarring in at least one of the treated areas.Alma inc.Requested the facility to provide patient photographs for assessment; as of today no photographs have been received.In the absence of visual evidence, alma cannot validate the presence of scars.Based on internal company procedures, alma is submitting the report to the fda at this time.
Event or Problem Description
The suspected device was used on patient's back of legs (calves), elbows, buttocks and hips (outer) for hair removal.As per the facility, patient with skin type v/vi sustained blisters and burns on all areas.The facility provided care for wounds by cleaning and hydrating.Patient was also provided aloe/aquaphor.These injuries were diagnosed as 1st and partial 2nd degree burns.

• Brand Name: SOPRANO ICE
• 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: 8279869
• Report Number: 3004167969-2019-00005
• Device Sequence Number: 2357699
• Product Code: GEX
• UDI-Device Identifier: 17290110120693
• UDI-Public: 17290110120693
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140009
• 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): 12/26/2018

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: Other
• Device Model Number: 810
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 12/26/2018
• Device Age: 10 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 01/25/2019
• 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