inforMED

BELLARRUM UVA TANNING BED

Received Mar 21, 1994

Report MW4000321 · MDR key 12156

Device

Model number

C-24

Patient

17 YR

  • Burn(s)
  • Skin Discoloration

Narrative

Description of Event or Problem

COMPLAINANT'S 17-YR-OLD DAUGHTER HAS BEEN TANNING AT THIS ESTABLISHMENT AND LATELY HAS BEEN BURNT AND LOOKED JAUNDICED. SHE WAS STAYING IN THE TANNING BED 40-50 MINS. IN CONVERSATIONS WITH CDRH MFRS, MAX EXPOSURE TIME SUGGESTED IS 20 MINS. TANNING CTR WAS VISITED AND FIELD TEST PERFORMED. TANNING CTR HAS SIX TANNING BEDS WHICH UTILIZE 24 BULBS (12 ON TOP/12 ON BOTTOM). THERE IS ALSO A 40 BULB TANNING BOOTH (ANOTHER MFR'S). INVESTIGATION SHOWED NO EVIDENCE THAT CUSTOMERS WERE USING TANNING BEDS FOR 40-50 MINS. THREE FIELD EXAMS WERE CONDUCTED. THE ONLY DEFICIENCIES NOTED DURING THE TESTING OF THESE UNITS WAS THAT ONE TIMER COULD BE SET FOR 30 MINS INSTEAD OF THE MFR'S RECOMMENDED 20 MINS, AND THE FIRM WAS UNABLE TO PROVIDE ANY INSTRUCTIONS FOR OPERATIONS MANUALS. THIS INSPECTION FAILED TO REVEAL ANY CLASS A DEFICIENCIES.