MAUDE Adverse Event Report: THE DAAVLIN DISTRIBUTING CO. DAAVLIN 7 SERIES PHOTOTHERAPY EQUIPMENT; 7 SERIES CT

Model Number	7 SER CT 311-8100-120V 50/60HZ
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Partial thickness (Second Degree) Burn (2694)
Date of Event	07/02/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient did not contact prescribing doctor for dosing information prior to treating with new equipment.Patient had severe erythema with blistering after first treatment.Patient required medical attention and was admitted into the hospital.
Additional Manufacturer Narrative
No problem found with device.This was an operator error.

• Brand Name: DAAVLIN 7 SERIES PHOTOTHERAPY EQUIPMENT
• Common Device Name: 7 SERIES CT
• Manufacturer (Section D): THE DAAVLIN DISTRIBUTING CO.; 205 west bement street; po box 626; bryan OH 43506
• Manufacturer (Section G): THE DAAVLIN DISTRIBUTING CO.; 205 west bement street; po box 626; bryan OH 43506
• Manufacturer Contact: michele thiel ; 205 west bement street; po box 626; bryan, OH 43506 ; 4196366304
• MDR Report Key: 19911558
• Report Number: 1526255-2024-00001
• Device Sequence Number: 8618792
• Product Code: FTC
• UDI-Device Identifier: B280808HO0008CT60
• UDI-Public: B280808HO0008CT60
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K212510
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/01/2024

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 SER CT 311-8100-120V 50/60HZ
• Device Catalogue Number: 808HO0008CT6
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2024
• Initial Report FDA Received Date: 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/27/2024
• 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: Hospitalization
• Patient Sex: Prefer Not To Disclose