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

Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Herpes (1898)
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).Multiple attempts were made to retrieve the device but it has not been returned.The customer stated that the device has been working fine since the incident.In absence of adequate data, investigation cannot be conducted to determine the root cause.Alma lasers reached out to two independent medical experts for injury diagnosis based on available photographs.Both experts evaluated this as a reversible injury with the healing time of few weeks.Based on the non-permanent nature of injury, this event was deemed not reportable.Multiple patient out come follow-up attempts were made.On 05/29/2018 the facility updated that there was no hyperpigmentation but patient still had grid marks on her chest.Alma treated this as additional information and requested additional photos which were not provided.In absence of photos, patient's condition cannot be ascertained.Even though it cannot be confirmed if it is a permanent injury, alma is submitting this report in good faith efforts due to the presence of alleged grid marks on patient's chest.
Event or Problem Description
The suspected device was used on patient's neck, face and chest.As per the facility, the alleged injury was diagnosed as cold sores on face and neck.The facility did not provide any treatment/handpiece details and was unresponsive to alma's multiple attempts to obtain information.

• Brand Name: CO2
• 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: 7648048
• Report Number: 3004167969-2018-00006
• Device Sequence Number: 16212108
• Product Code: GEX
• UDI-Device Identifier: 17290110120952
• UDI-Public: 17290110120952
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K072182
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/29/2018

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: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2018
• Device Age: 10 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2018
• Initial Report FDA Received Date: 06/28/2018
• 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: Disability