MAUDE Adverse Event Report: THE DAAVLIN DISTRIBUTING CO. DAAVLIN 7 SERIES

Model Number	7 SERIES
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	10/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We, the manufacturer have investigated the reported incident.The device was found to have been purchased via an unauthorized third-party (thrift store) and used by a consumer without medical prescription or supervision, as show on the labels.The patient reported using the device for a duration exceeding the maximum recommended exposure time, having misinterpreted the medical device as a consumer tanning unit.Investigation of the device (or device records) indicates the device functioned according to specifications.No device malfunction was identified.The event is attributed to off-label misuse.
Event or Problem Description
This is in response to previously filed maude report mw5180372.Patient purchased device from thrift store that advertised it as a tanning bed, and recommended a 6 minute treatment time.Patient felt uncomfortable "several minutes" into treatment, and experienced significant erythema 12 hours later, leading the patient, in confusion, to seek medical treatment.

• Brand Name: DAAVLIN 7 SERIES
• Common Device Name: 7 SERIES
• 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: 24652618
• Report Number: 1526255-2026-00001
• Device Sequence Number: 5664417
• Product Code: FTC
• UDI-Device Identifier: B280808HO0004CT6ND00
• UDI-Public: B280808HO0004CT6ND00
• Combination Product (Y/N): N
• PMA/510(K) Number: K212510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2026

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: 7 SERIES
• Device Catalogue Number: 808HO0004CT6ND
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2026
• Initial Report FDA Received Date: 03/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/25/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 70 YR
• Patient Sex: Male