DW-1C DWFA-1CRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08800050100000), received between Dec 22, 2025 and Dec 22, 2025 — classified as 1 injury.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (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.

• InjuryDec 22, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  ON (B)(6) 2025, THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE PATIENT DEVELOPED REDNESS WITH STREAKING AND SWELLING ALONG THE LEFT CHEEK APPROXIMATELY 10 DAYS POST-TREATMENT, FOLLOWING ACCIDENTAL CONTACT WITH THE TREATED AREA. THE PATIENT SUBSEQUENTLY DEVELOPED AN OPEN WOUND, AND DERMATOLOGY EXPRESSED CONCERN REGARDING ACTIVE BLEEDING. THE PATIENT HAS BEEN EVALUATED BY A NURSE PRACTITIONER (NP) AND A MEDICAL DOCTOR (MD) AND IS CURRENTLY ON A SECOND COURSE OF ANTIBIOTICS. THE HCP REQUESTED CONSULTATION WITH THE MEDICAL DIRECTOR FOR FURTHER CLINICAL GUIDANCE. ON DECEMBER 20, 2025, THE MEDICAL DIRECTOR SPOKE WITH THE HCP TO DISCUSS THE CASE AND PROVIDE GUIDANCE. PATIENT OUTCOME REMAINS PENDING AT THE TIME OF THIS REPORT. UPDATE WILL BE PROVIDED IF AND WHEN IT BECOMES AVAILABLE. UPDATE: ON JANUARY 5TH, 2026, A FOLLOW UP EMAIL WAS SENT TO THE SALES REPRESENTATIVE TO CHECK ON THE STATUS OF THE PATIENT. NO RESPONSE WAS RECEIVED. ON JANUARY 13TH, 2026, ANOTHER FOLLOW UP EMAIL WAS SENT TO CHECK ON THE STATUS OF THE PATIENT. THE SALES REPRESENTATIVE PROVIDED AN UPDATE FROM A TEXT EXCHANGE IN WHICH THE HCP REPORTED THAT THE PATIENT WAS SEEN BY DERMATOLOGIST AND DIAGNOSED WITH A GRANULOMA. T

  Patient problems: Erythema; Granuloma; Nodule

  MAUDE report 23865697 ↗