MAUDE Adverse Event Report: CANDELA CORPORATION CO2RE

Model Number	FG70412US
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Scar Tissue (2060)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Based upon evaluation by the candela field service engineer, the system would not have contributed to the reported event.Treatment parameters were not provided.Therefore, it is undeterminable if the customer performed a test spot, used the correct system settings/technique as described in the treatment guidelines for the device in use.Clinical training request was sent to (b)(6) clinical training to provide additional clinical education for the clinic.The investigation findings do not lead to a clear conclusion about the cause of the reported event.Additional information has been solicited.If new and relevant information becomes available, a supplemental report will be submitted.Review of risk management documents demonstrate that the reported risk is captured and assessed.No further corrective actions required for this complaint at this time.Risk information is then subject to periodic risk reviews and trend tracking.
Event or Problem Description
While providing clinical training at a customer clinic in california, the (b)(6) clinical trainer was approached by a physician who was not participating in the training but wanted to review an alleged reaction from a treatment with another candela device in the clinic.The physician presented a photo of a patient's skin reaction post treatment with a core device.The image showed a female with visible scarring over the neck and chest area.No patient history or treatment parameter details provided.The image was reviewed with (b)(6) clinical team.Based on limited information available, it appears that the scars will result in permanent damage and may require surgical intervention.Additional information has been solicited.No further information received to date.The case will be reassessed upon receipt of new and/or relevant information.

• Brand Name: CO2RE
• Common Device Name: CO2RE
• Manufacturer (Section D): CANDELA CORPORATION; p.o. box 550; industrial zone, tavor buildin; yokneam illit, yokneam illit 20692 00; IS 2069200
• Manufacturer (Section G): CANDELA CORPORATION; p.o. box 550; industrial zone, tavor buildin; yokneam illit, yokneam illit 20692 00; IS 2069200
• Manufacturer Contact: greg wallender ; 251 locke drive; marlborough, MA 01752 ; 5083587400
• MDR Report Key: 15811863
• Report Number: 3003772750-2022-00001
• Device Sequence Number: 20270658
• Product Code: GEX
• UDI-Device Identifier: 07290109952116
• UDI-Public: 07290109952116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K181523
• 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
• Report Date (Section B): 10/18/2022

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: FG70412US
• Device Catalogue Number: FG70412US
• 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: 10/18/2022
• Initial Report FDA Received Date: 11/17/2022
• 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