PDS D6262Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10705031026223), received between Feb 10, 2023 and Mar 17, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 17, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. THE SUTURE WAS BROKEN DURING INTERRUPTED SUTURING ON DERMIS. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16567971 ↗
• MalfunctionFeb 10, 2023Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A MASTECTOMY PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. ALTHOUGH THE SUTURE BROKE DURING USE ON DERMIS, THE PRODUCT WAS USED ON THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16353115 ↗