Handpiece Cooled Dye VL (3) For HXL 1Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 17290110120327), received between Jun 8, 2018 and Nov 28, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 28, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S CHEST FOR LESIONS AT (B)(6) CLINIC IN (B)(6).

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 8112496 ↗
• InjuryNov 14, 2018Output below Specifications; Output below Specifications

  THE SUSPECTED DEVICE WAS USED ON PATIENT'S CHEST AND SHOULDERS.

  Patient problems: Burn(s)

  MAUDE report 8069917 ↗
• InjurySep 12, 2018Output below Specifications; Output below Specifications

  THE SUSPECTED DEVICE WAS USED ON PATIENT'S THIGHS BILATERALLY FOR LEG VEINS. THE FACILITY DIAGNOSED THE INJURY AS A BURN.

  Patient problems: Partial thickness (Second Degree) Burn; Skin Discoloration; Superficial (First Degree) Burn

  MAUDE report 7870367 ↗
• InjuryJun 8, 2018Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT WITH SKIN TYPE III-IV ON THE ABDOMEN, UPPER PORTION OF BACK AND LOWER BREAST AREA FOR LESIONS. AS PER THE FACILITY NOTES, PATIENT CALLED THEM ON (B)(6) 2018 ABOUT DEVELOPING REDNESS IN SOME OF THE TREATED AREAS. FACILITY TOLD THE PATIENT TO COME IN FOR EVALUATION AND RECOMMENDED BACITRACIN OINTMENT. UPON FOLLOW-UP, PATIENT REPORTED THAT SHE HAS DEVELOPED BLISTERS. FACILITY DIRECTED THE PATIENT TO VISIT THEM FOR EVALUATION. BLISTERS WERE NOTED ON ABDOMINAL AND CHEST AREA, HOWEVER, NO BLISTERS WERE OBSERVED ON THE BACK. IT WAS RECOMMENDED TO THE PATIENT TO SEE A DERMATOLOGIST. AS PER THE FACILITY, PATIENT TOLD A STAFF MEMBER THAT SHE DID NOT APPLY BACITRACIN OINTMENT AS SUGGESTED THE DAY BEFORE. IT WAS REPORTED THAT THE PATIENT WAS USING MEDICATIONS VYTORIN AND SYNTHROID. HER HEALTH AT THE TIME OF TREATMENT AND COMPLAINT WAS DESCRIBED AS GOOD. PATIENT THEN WENT TO SEE THE DERMATOLOGIST WHO GAVE THE DIAGNOSIS OF SECOND DEGREE BURNS AND PRESCRIBED 10 G STRATADERM. FACILITY REPORTED THE ALLEGED ADVERSE EVENT TO ALMA LASERS ON (B)(6) 2018.

  Patient problems: Erythema; Partial thickness (Second Degree) Burn

  MAUDE report 7585048 ↗