MAUDE Adverse Event Report: THE DAAVLIN DISTRIBUTING CO. PHOTHERA 600; P600-3D

Model Number	P600-3D
Medical Device Problem Code	Use of Incorrect Control/Treatment Settings (1126)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	03/23/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's settings were not successfully saved with the changed min on of 10, and on the first treatment (nominally 200mj front and back), the device delivered light for 1:02 and 1:56.Patient had significant erythema and reached out to their hcp at geissinger.
Additional Manufacturer Narrative
An internal investigation initiated on march 4, 2026, identified a firmware/hardware interaction issue in model (b)(4) devices using software version 3.17.The issue is specifically tied to the rev h "no sensor" clearlink main board and the rev d "ams osram" remote sensor board.Testing confirmed the uv sensor gain can fail to apply correctly during the initialization function at power-up.When this occurs, the gain may default to a lower value (4 or 5) instead of the configured value (7 for uvb), leading to incorrect calibrated output calculations.The patient's overexposure was a direct result of this "dropped" gain state combined with the failure of the device to save updated settings to the intended min_on threshold.A "stop ship" was issued on march 4, 2026.The planned 806 report covers (b)(4) devices and includes a temporary field fix to adjust the min_on value.This adjustment is designed to ensure the device operates in fixed calibration or detects a dropped gain to prevent future overexposure events.

• Brand Name: PHOTHERA 600
• Common Device Name: P600-3D
• Manufacturer (Section D): THE DAAVLIN DISTRIBUTING CO.; 205 west bement street; bryan OH 43506
• Manufacturer (Section G): THE DAAVLIN DISTRIBUTING CO.; 205 west bement street; bryan OH 43506
• Manufacturer Contact: michele thiel ; 205 west bement street; bryan, OH 43506 ; 4196366304
• MDR Report Key: 24767421
• Report Number: 1526255-2026-00002
• Device Sequence Number: 9153657
• Product Code: FTC
• UDI-Device Identifier: 00810182930305
• UDI-Public: 00810182930305
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K212510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 04/02/2026

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: Lay User/Patient
• Device Model Number: P600-3D
• Device Catalogue Number: 6D10NCL8
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2026
• 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: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: TO BE PROVIDED
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male