MAUDE Adverse Event Report: CANDELA CORPORATION GENTLEMAX PRO PLUS LASER SYSTEM; GENTLE MAX PRO PLUS

Model Number	9914-CE-9036
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Burn(s) (1757)
Type of Reportable Event	Serious Injury
Event or Problem Description
A customer in france reported a burn to candela france.The doctor reported that a male patient had nd: yag vascular treatment with gentlemax pro plus laser for a senile angioma on the lower lip, approximately (b)(6) 2025.The patient reported that it "continued to grow" and he "went to the emergency room due to significant bleeding three (3) to (4) weeks post treatment." emergency room treatment information was not provided.Per review by candela medical director, the post photo appears to show bleeding.There is, however, insufficient information without ability to review more recent photos to determine if the impact may result in permanent damage to a body structure.While the mucosa and lip generally heal well, if the depth and volume of the lesion is significant there could be resultant scarring.Additional information has been solicited.
Event or Problem Description
A customer in france reported a burn to candela france.The doctor reported that a male patient had nd: yag vascular treatment with gentle max pro plus laser for a senitle angioma on the lower lip, approximately (b)(6) 2025.The patient reported that scarring.Addiat it "continued to grow: and he went to the emergency room due to significant bleeding three (3) to (4) weeks post treatment." emergency room treatment information was not provided.Per review by candela medical director, the post photo appears to show bleeding.There is, however, insufficient information without ability to review more recent photos to determine if the impact may result in permanent damage to the body structure.While the mucosa and lip generally heal well, if the depth and volume of the lesion is significant there could be resultant scarring.Additional information has been solicited.
Additional Manufacturer Narrative
Candela svp, clinical operations and medical director reviewed available clinical information noting "ndyag should not be overlapped.This report form states that technique is 30 percent overlap in daisy pattern, ie multiple overlapping pulses.Review of the patient impact form reveals that the treatment technique was not in accordance with treatment guidelines.Therefore, the most probable cause of this reported injury was due to unintended use error caused or contributed to event.The interaction between the user and device, or sample, caused or contributed to the error.This includes unintended inappropriate use of the device and incorrect sample preparation.

• Brand Name: GENTLEMAX PRO PLUS LASER SYSTEM
• Common Device Name: GENTLE MAX PRO PLUS
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): CANDELA CORPORATION; 291 locke drive; marlborough MA 01752
• Manufacturer Contact: greg walleder ; 291 locke dr; marlborough, MA 01752 ; 9495997654
• MDR Report Key: 22288041
• Report Number: 3016496662-2025-00002
• Device Sequence Number: 8836573
• Product Code: GEX
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K201111
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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 Model Number: 9914-CE-9036
• Device Catalogue Number: 9914-CE-9036
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 06/18/2025
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male