Diode 810nm Handpiece for SopranoRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 17290110120662), received between Jan 11, 2019 and Feb 8, 2019 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (5 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 8, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S SUPRAPUBIC AREA IN LINEAR APPEARANCE FOR HAIR REMOVAL. AS PER THE FACILITY, AFTER THE TREATMENT, BIKINI BURNS APPEARED THAT NIGHT WHICH SCABBED EVENTUALLY. THE FACILITY SAW THE PATIENT AGAIN AFTER A MONTH AND REPORTED THAT THE PATIENT HAD HYPOPIGMENTATION.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 8323564 ↗
• InjuryJan 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S ANTERIOR ENTIRE LEGS AND RIGHT INNER THIGH FOR UNWANTED HAIR. AS PER THE FACILITY, PATIENT SUSTAINED BURNS UP AND DOWN THE LEGS WITH SCABBING. THE RIGHT INNER THIGH AREA HAD BROKEN SKIN. THE BURNS APPEARED IN THE EVENING AFTER TREATMENT. THE FACILITY PROVIDED PATIENT WITH NEOSPORIN TO APPLY TO ALL AREAS WITH LIGHT DRESSINGS. AS PER THE FACILITY, THE PATIENT HAS ON-GOING PIGMENTATION.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 8242543 ↗
• InjuryJan 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON THE INNER ASPECT OF RIGHT LOWER LEG BELOW THE KNEE FOR UNWANTED HAIR. AS PER THE FACILITY, PATIENT SUSTAINED PAINFUL BLISTERS/REDNESS ON RIGHT LOWER EXTREMITIES. THE PATIENT WAS SEEN BY THE FACILITY AGAIN AND IT WAS NOTED THAT THERE WAS ONGOING PIGMENTATION.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 8242527 ↗
• InjuryJan 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S LOWER LEGS (BELOW KNEES TO ANKLES) FOR UNWANTED HAIR. PATIENT BLISTERED ALL UP AND DOWN ON ANTERIOR SHINS THAT EVENING. PATIENT WAS SEEN BY THE FACILITY AGAIN AND HYPOPIGMENTATION WAS NOTED.

  Patient problems: Burn(s); Skin Discoloration

  MAUDE report 8242512 ↗
• InjuryJan 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  THE SUSPECTED DEVICE WAS USED ON THE PATIENT'S UPPER BACK AND RIGHT LOWER ARM FOR HAIR REMOVAL. PATIENT SUSTAINED MULTIPLE AREAS OF ERYTHEMA ON THE UPPER BACK AND LEFT SIDE OF THE RIGHT ARM WITH BLISTERS. PATIENT ALSO SUSTAINED MULTIPLE BLISTERS ON THE BACK AND THE LEFT SIDE SHOULDER. THE FACILITY PROVIDED PATIENT WITH NEOSPORIN AND ADVISED AQUAPHOR TID.

  Patient problems: Burn(s); Erythema

  MAUDE report 8242478 ↗