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

Model Number	UHU-318
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	04/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient was receiving first treatment at metro dermatology to treat skin condition.Clinic was to impart 200 mj/cm2 dosage.Clinic was operating the device using admin mode which requires that the device lamp output be entered manually in order to determine the exposure time to uv light.The read out of the unit was 6.11 mw/cm2.The technician running the device input 0.61 mj/cm2 in error.Time of exposure is calculated by dividing the dosage desired for the treatment by the device output, so instead of dividing by 6.11, 0.61 was used.This resulted in an exposure time of 5 min and 28 sec instead of 33 sec.The patient received burns over a large part of her body and her skin was reddened, peeling and extremely painful.After consulting with her physician, she was prescribed triamcinolone acetonide0.025% ointment to treat the skin.Patient's condition has been monitored by the clinic and she was expected to return for additional treatment.

• Brand Name: PANOSOL 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 mercantile rd.; beachwood OH 44122
• Manufacturer Contact: jeffrey girimont ; 23700 mercantile rd.; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 19305746
• Report Number: 1521608-2024-00002
• Device Sequence Number: 7310186
• Product Code: FTC
• UDI-Device Identifier: 00816878020404
• UDI-Public: (01)00816878020404(11)230725
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K041212
• 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): 05/13/2024

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: Health Professional
• Device Model Number: UHU-318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/22/2023
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female