National Biological Corporation UHU-318Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816878020404), received between May 13, 2024 and May 13, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K041212); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMay 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  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.

  Patient problems: Burn(s)

  MAUDE report 19305746 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K041212. One submission often covers many models, so check the product and lot details in each record.

• Z-1309-2008 · Feb 19, 2008 · Terminated
  HOUVA III Phototherapy System with DermaSense Technology comes on one skid within 10 cardboard boxes. A therapeutic product designed for individuals who require specific Ultraviol