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

Model Number DYE VL

Device Problem Output below Specifications (3004)

Patient Problem Burn(s) (1757)

Event Date 05/24/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).(b)(4) (importer) evaluated the device.It was found that the device energy output was below specifications.(b)(4) was recently made aware of an incident that "ocurred" in 2017 through a third-party.(b)(4) made multiple attempts to obtain information about the alleged incident from the facility, however, received no response.In "absense" of any information, (b)(4).Regulatory advised to perform another follow-up in case any additional details become available.On 11/01/2018, (b)(4) received additional information from a third party.After the review, (b)(4) clinical concluded that given the information pertaining to patient's skin condition even after 90 days, the event is to be reported in compliance with the company's protocol and in good faith.In the absence of pertinent clinical parameters and photographs, (b)(4) clinical cannot fully ascertain the root cause.

Event Description

The suspected device was used on patient's chest and shoulders.

• Brand Name: HARMONY XL
• Type of Device: MEDICAL LASER
• Manufacturer (Section D): ALMA LASERS LTD; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• Manufacturer Contact: ariela albalak ; 14 & 15 halamish st. pob 3021; caesarea north industrial park; caesarea hazafon 3088900, ; IS
• MDR Report Key: 8069917
• MDR Text Key: 127121773
• Report Number: 3004167969-2018-00010
• Device Sequence Number: 1
• Product Code: GEX
• UDI-Device Identifier: 17290110120327
• UDI-Public: 17290110120327
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072564
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: DYE VL
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/20/2018
• Device Age: 4 YR
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/11/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Disability
• Patient Age: 38 YR