MAUDE Adverse Event Report: NATIONAL BIOLOGICAL CORPORATION PANOSOL II 6 FT.; PHOTOTHERAPY UNIT

Model Number UVB-661

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 05/16/2022

Event Type  Injury  

Event Description

Patient reported that she was diagnosed with 2nd degree burns from overtreatment when using her uv phototherapy device for the first time.The patient sought medical attention and was prescribed with a topical steroid (triamcinolone) for treatment.

Manufacturer Narrative

National biological is still in the process of investigating this incident.Patient claims to have used minimum exposure dosage for skin type iii that she was diagnosed as.The patient was in mexico prior to treatment but claims not to have been exposed to the sun which could have affected treatment times.The patient was also recovering from a surgical procedure after which she was prescribed nsaids drugs for pain.These types of drugs cause photosensitivity in some patients.Also investigating whether her skin type was assigned correctly.Patient currently plans to keep the equipment and s waiting for more information before resuming treatment.

• Brand Name: PANOSOL II 6 FT.
• Type of Device: PHOTOTHERAPY UNIT
• Manufacturer (Section D): NATIONAL BIOLOGICAL CORPORATION; 23700 mercantile rd.; beachwood OH 44122
• Manufacturer Contact: jeffrey girimont ; 23700 mercantile rd.; beachwood, OH 44122 ; 2168310600
• MDR Report Key: 14684146
• MDR Text Key: 293919036
• Report Number: 1521608-2022-00002
• Device Sequence Number: 1
• Product Code: FTC
• UDI-Device Identifier: 0081687802099
• UDI-Public: (01)0081687802099(11)220318
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: UVB-661
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• Date Device Manufactured: 04/19/2022
• 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: 29 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian