MAUDE Adverse Event Report: CANDELA CORPORATION SYNERON CO2RE SYSTEM; CO2 LASER

Model Number	CO2RE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Tissue Injury (4559)
Date of Event	05/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
A patient advocate reported that a female patient was treated with a co2re laser at a clinic in new jersey on (b)(6) 2021, alleging that the patient sustained unspecified injuries.No patient history, medications, nor fitzpatrick skin type was provided.No treatment details / treatment parameters were provided.No injury details nor medical intervention provided.Documentation notes that the device used for the treatment was rented from a third-party entity.There is no further information available at this time to assess.The documentation received included an affidavit statement from a medical doctor (md) noting that "within a reasonable degree of medical probability that the patient has sustained permanent injury." the md does not state the type of injury and / or any treatment intervention required, only that there is "permanent injury," therefore, candela is reporting this event.
Additional Manufacturer Narrative
The device was not evaluated.Therefore, it cannot be determined if the equipment was operating within specification.The co2re user manual lists the following side effects: tenderness, purpura, erythema lasting longer than normal, edema, bruising, damage to natural skin texture (scratching, crusting, blister, burn), hyperpigmentation or hypopigmentation, herpes simplex, bacterial and / or fungal infection, scarring.However, an unspecified event was reported.As a result, the investigation findings do not lead to a clear conclusion about the cause of the reported event.The investigation findings do not lead to a clear conclusion about the cause of the reported event.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, which may require additional actions and / or review.

• Brand Name: SYNERON CO2RE SYSTEM
• Common Device Name: CO2 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; marlborough, MA 01752 ; 5083587400
• MDR Report Key: 17270789
• Report Number: 3016496662-2023-00005
• Device Sequence Number: 3566863
• Product Code: GEX
• UDI-Device Identifier: 07290109952116
• UDI-Public: 07290109952116
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023

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: CO2RE
• Device Catalogue Number: FG70412US
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Disability
• Patient Sex: Female