MAUDE Adverse Event Report: CANDELA CORPORATION GENTLEMAX

Model Number 9914-00-0400

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Numbness (2415); Full thickness (Third Degree) Burn (2696); Blister (4537)

Event Date 03/31/2018

Event Type  Injury  

Manufacturer Narrative

Became aware of event through receipt of legal action notification.Product investigation may or may not be performed due to potential legal action limitations, access to device, and cooperation of customer.Additional information solicited.Supplemental report will be filed upon receipt of new relevant information / investigation conclusion.

Event Description

Patient advocate notified candela alleging female patient (b)(6) had laser hair removal treatment with a gentlemax laser on (b)(6) 2018 resulting in burns.(b)(6) reported that prior treatments went well.It was reported that upon return from vacation patient was advised to reschedule due to tanned skin; appointment was rescheduled for (b)(6) 2018.(b)(6) reported she was still tan when she arrived for her appointment; however, treatment proceeded.(b)(6) reported the procedure differed from previous treatments; she felt "extreme" pain and some numbness in her left arm.The provider lowered the power and proceeded with treatment.Post treatment , patient reported that she complained of "excruciating" pain and began to see immediate blisters appear on her left arm.She reported that she received an unspecified "ointment" and told to apply to the affected area.Further treatment intervention was not reported.It was reported that (b)(6) continues to require treatment today and that the extent of injuries, disabilities and future treatment has not been determined.

• Brand Name: GENTLEMAX
• Type of Device: GENTLEMAX
• Manufacturer (Section D): CANDELA CORPORATION; 530 boston post road; wayland MA 01778
• Manufacturer Contact: yverre bobay ; 530 boston post road; wayland, MA 01778
• MDR Report Key: 10617118
• MDR Text Key: 209535747
• Report Number: 1218402-2020-00037
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K140122
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/31/2020

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: No Information
• Device Model Number: 9914-00-0400
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/31/2020
• Initial Date FDA Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: No
• 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