Handpiece SHR Pro Cooled (6.4) For HXL 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 17290110120389), received between Feb 7, 2019 and Feb 7, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2019Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S LEFT SHOULDER BLADE FOR HAIR REMOVAL. AS PER THE FACILITY, THE AREA WAS NOT COVERED WITH ANYTHING AND AFTER TREATMENT, THE SKIN AROUND THE TATTOO BECAME RED AND INFLAMED ALMOST LIKE A BURN. THE PATIENT COMPLAINED THAT IT WAS PAINFUL. AFTER FEW HOURS, THE REDNESS AND TENDERNESS DISAPPEARED. FEW DAYS LATER, FACILITY NOTICED SCABS ON THE TATTOO AND THAT THE SKIN ON PIGMENT WAS PEELING. ACCORDING TO THE FACILITY NOTES, THIS INJURY WAS DIAGNOSED AS A BURN.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 8317010 ↗