MAUDE Adverse Event Report: NATIONAL BIOLOGICAL CORPORATION PANOSOL 6-3D; UV PHOTOTHERAPY DEVICE

Model Number	UVB-680
Medical Device Problem Codes	Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient has been diagnosed with psoriasis vulgaris (l40.0).Her doctor prescribed the use of a panosl 63d (ultraviolet light therapy system) to treat her condition at home because of frequent flareups of the disease.Patient was advised that she would need 2-3 treatments per week and that she would be contacted by a doctor to provide more detail regarding her treatment protocol.Upon receipt of her equipment, the patient still had not received the call from the physician and decided to begin treatment on her own.Using her previous tanning experience as a baseline, the patient decided to use an initial treatment time of seven minutes.She did not refer to the recommended protocols included in the device operations manual nor consult her physician or natbio prior to the treatment.This arbitrary treatment time does not correspond to the recommended protocol for her skin type (fitzpatrick skin type ii) nor any other phototherapy protocol.As a result, the patient received first degree burns across her body.She sought treatment for her burns at a local emergency room and was prescribed ibuprofen and pyregesic to treat the injuries.Her current condition is much improved with skin redness and swelling having subsided.The patient is eager to return to phototherapy treatments and will recommence upon meeting with her dermatologist.

• Brand Name: PANOSOL 6-3D
• Common Device Name: UV PHOTOTHERAPY DEVICE
• Manufacturer (Section D): NATIONAL BIOLOGICAL CORPORATION; 23700 mercantile rd.; beachwood OH 44122
• Manufacturer (Section G): NATIONAL BIOLOGICAL CORPORATION; 23700 mercantie rd.; beachwood OH 44122
• Manufacturer Contact: jeffrey girimont ; 23700 mercantile rd.; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 20925440
• Report Number: 1521608-2024-00003
• Device Sequence Number: 17466425
• Product Code: FTC
• UDI-Device Identifier: 00850054882141
• UDI-Public: (01)00850054882141(11)241111
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K872650
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/13/2024

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: UVB-680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Initial Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/11/2024
• 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: 24 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White