MAUDE Adverse Event Report: DERMASENSOR INC DERMASENSOR; SOFTWARE-AIDED ADJUNCTIVE DIAGNOSTIC DEVICE FOR USE BY PHYSICIANS ON LESIONS SUS

Model Number	10101
Medical Device Problem Codes	Nonstandard Device (1420); Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is for device s/n (b)(6) where the correct, unique spectrometer ids and their associated coefficients were not correctly configured.The installed spectrometer did not correctly analyze the wavelengths of light which resulted in lower device result scores, which may impact the clinician's care and result in delay of referral to a dermatologist.There is no assertion of discrete patient harm.The device is an adjunctive diagnostic device that is intended to provide additional information to clinicians, aiding in management but not used independently to determine management, diagnosis nor therapy.Dermasensor device should be used in conjunction with the totality of clinically relevant information from the clinical assessment in accordance with the device instructions for use, including visual analysis of the lesion, by physicians who are not dermatologists.The device should be used on lesions already assessed as suspicious for skin cancer and not as a screening tool.The device should not be used as the sole diagnostic criterion nor to confirm clinical diagnosis of skin cancer.

• Brand Name: DERMASENSOR
• Common Device Name: SOFTWARE-AIDED ADJUNCTIVE DIAGNOSTIC DEVICE FOR USE BY PHYSICIANS ON LESIONS SUS
• Manufacturer (Section D): DERMASENSOR INC; 801 brickell ave; ste 1610; miami 33131
• Manufacturer Contact: ryan freiden ; 801 brickell ave; #1610; miami, FL 33131
• MDR Report Key: 24195965
• Report Number: 3017254-2025-00004
• Device Sequence Number: 20849364
• Product Code: QZS
• UDI-Device Identifier: 00850017786004
• UDI-Public: 00850017786004
• Combination Product (Y/N): N
• PMA/510(K) Number: DEN230008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10101
• Device Catalogue Number: 10101
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/27/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3017254114-09242025-001-
• Patient Sequence Number: 1
• Patient Sex: Unknown