excel HRRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00816722021502), received between Jun 21, 2024 and Jun 21, 2024 — classified as 1 injury.

The most frequently reported specific device problem is “Output above Specifications” (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. How this data works · Data updated Oct 13, 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.

• InjuryJun 21, 2024Output above Specifications; Adverse Event Without Identified Device or Use Problem; Output above Specifications; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS TREATED WITH A 755 NM LASER FOR HAIR REDUCTION. THE TREATED AREA DEVELOPED SIGNIFICANT PERIFOLLICULAR ERYTHEMA AND EDEMA, WHICH WAS ORIGINALLY MISCHARACTERIZED AS BRUISING. PERIFOLLICULAR ERYTHEMA AND EDEMA ARE BOTH WELL-KNOWN AND DOCUMENTED EXPECTED TRANSIENT SIDE EFFECTS OF LASER HAIR REMOVAL TREATMENTS. THE ERYTHEMA AND EDEMA WERE MANAGED USING TOPICAL CREAMS CONTAINING 2% HYDROCORTISONE MIXED WITH BIAFINE AND HAVE RESOLVED. THE INITIAL MDR WAS FILED BECAUSE IT WAS BELIEVED THAT THE LASER MAY HAVE MALFUNCTIONED AND EMITTED SIGNIFICANTLY HIGHER PULSE ENERGY THAN EXPECTED; HOWEVER, THE INVESTIGATION HAS DETERMINED THAT THE ENERGY METER OR ENERGY DETECTOR HEAD USED BY THE FSE WHO VISITED THE SITE WAS MEASURING SIGNIFICANTLY DIFFERENT VALUES FOR SIMILAR ENERGIES WHEN DELIVERED INTO DIFFERENT SIZED TREATMENT SPOTS, WITH THE VARIANCE FROM NOMINAL BEING MONOTONICALLY HIGHER FOR LARGER SPOTS. THE ABSENCE OF ANY ERRORS BEING RECORDED IN THE DEVICE'S ERROR LOG CONFIRMS THAT THE DEVICE WAS FUNCTIONING FULLY AS INTENDED DURING THE TREATMENT IN QUESTION. SINCE THE LASER WAS FUNCTIONING AS INTENDED, THE INITIAL SERIOUS INCIDENT REPORT FILED IS HEREBY WITHDRAWN.

  Patient problems: Bruise/Contusion; Erythema; Swelling/ Edema

  MAUDE report 19582388 ↗