National Biological Corporation UVB-631-9Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00816878020770), received between Aug 18, 2022 and Feb 1, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Inadequate Instructions for Non-Healthcare Professional” (1 report).

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CALLED NATIONAL BIOLOGICAL CUSTOMER SERVICE FOR ADVICE ON EXPOSURE TIME FOR HER FIRST TIME USE OF NB-UVB PHOTOTHERAPY DEVICE. PATIENT HAD BEEN DIAGNOSED WITH MYCOSIS FUNGOIDES AND HER DOCTOR HAD NOT GIVEN ANY INSTRUCTION OF APPROPRIATE DOSAGE. DOCTOR WAS NOT AVAILABLE SO PATIENT REQUESTED ASSISTANCE FROM NATIONAL BIOLOGICAL. PATIENT HAD A KNOWN SKIN TYPE II BUT OPERATIONS MANUAL DOES NOT INCLUDE A PROTOCOL FOR HER DISEASE. OPERATIONS MANUAL LISTS AN INITIAL EXPOSURE TIME OF 1 MINUTE 13 SECONDS FOR A SKIN TYPE II PSORIASIS PATIENT AND WAS GIVEN THAT VALUE AS A RECOMMENDATION. PATIENT TREATED AT THAT TIME INTERVAL FOR BOTH FRONT AND BACK. SIX HOURS LATER SHE WAS EXPERIENCING SEVERE ERYTHEMA WITH PAIN AND REDDENING OF MOST OF HER EXPOSED AREAS. SHE CALLED DOCTOR AND WAS PRESCRIBED SILVER SULFADIAZINE FOR TREATMENT OF HER BURNS. SHE THEN REPORTED THE INCIDENT TO NATIONAL BIOLOGICAL VIA COMPANY EMAIL. PATIENT WAS INTERVIEWED ON (B)(6) 2024 AND WAS IN PEELING STAGE OF BURN BUT OTHERWISE IN ACCEPTABLE CONDITION. PATIENT CONSULTED HER PHYSICIAN AND IT WAS CONCLUDED THAT HER INITIAL EXPOSURE HAD BEEN TOO GREAT THEREBY CAUSING THE BURNS. SHE MAY HAVE HAD HEIGHTENED SENSITIVITY TO PHO

  Patient problems: Burn(s)

  MAUDE report 18627408 ↗
• InjuryAug 18, 2022Use of Device Problem; Inadequate Instructions for Non-Healthcare Professional; Patient Device Interaction Problem

  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 TR

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 15248235 ↗