UltraSlim Digital 60008Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00860925000338), received between Jan 6, 2023 and Mar 30, 2023 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ALLEGED BLISTERS / RASH ON PATIENT SKIN FOLLOWING RED LIGHT TREATMENT. PATIENT CLAIMS TO HAVE BEEN "BURNED." NOTE THAT BLISTERS WERE FOUND UNDER CLOTHING, AND NOT IN AREAS OF DIRECT EXPOSURE TO THE LIGHT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16643299 ↗
• InjuryMar 30, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MANUFACTURER RECEIVED NOTIFICATION ON 3/24/2023 OF AN EVENT REPORTED TO FDA BY A PATIENT. ACCORDING TO THE MEDWATCH NOTIFICATION, THE PATIENT ALEGES THAT TWO BLISTERS FORMED ON SKIN UNDERNEATH HER CLOTHING FOLLOWING RED LIGHT TREATMENT. PATIENT NARRATIVE FROM THE MEDWATCH FORM (MW5115842): "ON MY 3RD VISIT FOR ULTRASLIM RED LIGHT THERAPY 2 BLISTERS OCCURRED ON MY LEFT BREAST MEDIAL. THE TREATMENT WAS FOR MY NECK BUT THE LIGHT WAS SO POSITIONED THAT IT COVERED OVER MY LEFT BREAST WHICH. I WAS WEARING A TWO LAYER CAMISOLE AND NO ADDITIONAL COVERING WAS USED. I TOLD THE OWNER ABOUT THE BLISTERS WHEN SHE RETURNED FROM BEING OUT OF TOWN. THE NEXT TREATMENTS WERE DONE USING A MAT THAT COVERED THAT AREA. WHO KNEW THIS WOULD BECOME COMPLICATED. I DIDN'T HEAL WELL AS I'VE HAD MANY RECONSTRUCTIVE SURGERIES ON MY CHEST AS I AM A BREAST CANCER SURVIVOR. I HAVE SEEN MANY DOCTORS AND I WAS TOLD IT WOULD PROBABLY HAVE TO HAVE A REVISION SURGERY ON THAT BREAST. THE OWNER (B)(6) WAS REALLY SORRY ABOUT IT AND WANTED TO TALK TO MR. (B)(6) THE DEVELOPER OF THE RED LIGHT THERAPY. I JUST THOUGHT THE FDA SHOULD KNOW ABOUT THIS HAZARD."

  Patient problems: Blister

  MAUDE report 16643106 ↗
• InjuryJan 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CLAIMS TO HAVE RECEIVED BURN DURING LLLT TREATMENT USING RED LED COLD LIGHT. HOWEVER, THE DOCTOR WAS NOT ABLE TO CONFIRM THAT IT WAS A BURN, OR THAT IT OCCURRED AS A RESULT OF LLLT TREATMENT.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 16116993 ↗