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

Model Number UVB-631-9

Device Problems Use of Device Problem (1670); Inadequate Instructions for Non-Healthcare Professional (2956); Patient Device Interaction Problem (4001)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 07/22/2022

Event Type  Injury  

Event Description

Patient reported to have 2nd degree burns after treatment with uv phototherpy equipment.Patient had previous treatment history at dermatologist's office using a clinical phototherapy unit.A home unit was prescribed to her as she no longer wanted to go to the office for treament due to covid concerns.She sustained the burns upon her first usage of the equipment.Altthough she said she had read the operations manual, she used a 4 minute exposure time on both the front and back sides of her body.The recommended first usage treatment time per the operations manual for a person with her skin type (type ii) was 1 min 13 sec.She had decided to use the same time she had been using at the dermatologist's office (5 minutes) minus 1 minute even though there is no correlation regarding treatment times between clinical and home units.The patient misinterpreted the manual that stated that the previous exposure time should be used if treatment was interrupted for 8-11 days.This was not intended to mean that the previous time using a non-like unit should be used.The patient provided photos of her burns to her dermatologist and was prescribed antibiotics, steroids and a topical cream for treatment.

Manufacturer Narrative

Patient wanted to keep device, therefore it was never sent back to manufacturer for evaluation.

• Brand Name: PANOSOL 3D
• Type of Device: PHOTOTHERAPY UNIT
• 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: 23700 mercantile rd.; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 15248235
• MDR Text Key: 298114729
• Report Number: 1521608-2022-00003
• Device Sequence Number: 1
• Product Code: FTC
• UDI-Device Identifier: 00816878020770
• UDI-Public: (01)00816878020770(11)220614
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K872650
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UVB-631-9
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/16/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic