MAUDE Adverse Event Report: LUMENIS, LTD. M22; INTENSE PULSE LIGHT DELIVERY DEVICE

Model Number M22

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hypersensitivity/Allergic reaction (1907); Partial thickness (Second Degree) Burn (2694)

Event Date 05/17/2014

Event Type  Injury  

Event Description

A user facility reported that two (2) patients sustained blisters to the face following treatment with a lumenis m22 laser ipl handpiece.It was further reported by the user facility's physician that both patients have been treated to remediate the adverse events.

Manufacturer Narrative

The user facility's physician alleged that no operator manual was received in the shipment of the subject device on (b)(6) 2013.A review of the subject device shipment packaging checklist confirmed the operator manual was included with the system when shipped to the user facility.The lumenis m22 laser is a self-install system.An examination of the subject device by a lumenis technical expert concluded the device operated to manufacture specifications.No device malfunction was reported or observed.Subject device malfunction is not the suspected cause of the event reported.Reasonable attempts by phone and email were made to obtain further information from the user facility for the reported event including patient information, patient photographs, treatment settings, sun exposure and test patch, however, none was received; therefore, lumenis is unable to evaluate treatment parameters to determine their appropriateness for treatment and to determine a cause.Should more information with which to determine a cause be reported, a follow-up mdr will be filed.

• Brand Name: M22
• Type of Device: INTENSE PULSE LIGHT DELIVERY DEVICE
• Manufacturer (Section D): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer (Section G): LUMENIS, LTD.; 6 hakidma street po box 240; yokneam industrial park; yokneam, israel 2069 2; IS 20692
• Manufacturer Contact: brett godfrey ; 3959 west 1820 south; salt lake city, UT 84104 ; 8016562663
• MDR Report Key: 3882077
• MDR Text Key: 4511431
• Report Number: 3004135191-2014-00041
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2014

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
• Device Operator: Physician
• Device Model Number: M22
• Device Catalogue Number: GA-0005200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 06/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/18/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other