MAUDE Adverse Event Report: CANDELA CORPORATION NORDLYS; INTENSE PULSE LIGHT (IPL) & LASER

Model Number	9SYS7751-CNDL
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Burn(s) (1757); Full thickness (Third Degree) Burn (2696)
Date of Event	10/19/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Candela field service engineer (fse) evaluated the device and verified that the equipment does not give any failures.All device applicators were checked and were all within the correct range.Based upon evaluation the system would not have contributed to the reported event.A service history review revealed no similar complaints.There is nothing to indicate that the device was not used in accordance with treatment guidelines.The nordlys user manual lists burns as an adverse effect.Therefore, the cause for this event is known inherent risk of device indicating that the reported adverse event is known and documented in the labeling (including both short or long term known complications or adverse reactions).The reported adverse event is known as a potential side effect, per candela labeling, risk management & clinical documents.No further corrective actions are required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking, which may require additional actions and/or review.
Event or Problem Description
It was reported that a female patient with initial (b)(6) skin type iii was treated with a nordlys vl 555 applicator for the treatment of a port-wine stain on her neck, during a provider training at a clinic in spain on (b)(6) 2022.The patient did not have a history of prior sun exposure.A burn was noted immediately post-treatment.Blastoestimulina cream covered with linitul dressing and gauze and ice packs were applied immediately after treatment.Dermatologic and aesthetic treatment related burns that tend to be low grade and superficial (i.E., first-degree and second degree) additionally, the information reported did not indicate there was a death, serious injury, or medical intervention with this event; therefore, not a reportable injury.On (b)(6) 2022 the candela clinical trainer received new information/ images from the customer site of the patient's burn.It was noted that the treatment provider, a plastic surgeon, followed up with the patient and debrided the burn area, and prescribed chlorhexidine soap and gauze with silvederma cream, and covering the area from sun exposure.Follow-up information indicated that the injury is expected to heal.New information including post debridement images were reviewed with candela medical director and determined to be a full-thickness injury.Although noted as expected to heal, candela's position is to report an injury indicating a third-degree burn injury, affecting all layers of the skin within subcutaneous tissue.As such, an injury of this nature may lead to permanent underlying tissue damage.

• Brand Name: NORDLYS
• Common Device Name: INTENSE PULSE LIGHT (IPL) & LASER
• Manufacturer (Section D): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer (Section G): CANDELA CORPORATION; 251 locke drive; marlborough MA 01752
• Manufacturer Contact: greg wallender ; 251 locke drive; malborough, MA 01752 ; 5083587400
• MDR Report Key: 15954883
• Report Number: 3016496662-2022-00003
• Device Sequence Number: 7334507
• Product Code: GEX
• UDI-Device Identifier: 00817495023434
• UDI-Public: 00817495023434
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K212492
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2022

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: Health Professional
• Device Model Number: 9SYS7751-CNDL
• Device Catalogue Number: 9SYS7751-CNDL
• 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: 11/02/2022
• Initial Report FDA Received Date: 12/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female