BLAKE 2215Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10705031003514), received between May 23, 2022 and Aug 7, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryAug 7, 2024Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. ISSUE ENCOUNTERED WHEN REMOVING THE DRAIN. THE LATTER BROKE AT THE JUNCTION BETWEEN THE WHITE DRAINAGE PART AND THE TRANSPARENT PART. THE SCAR HAD TO BE REOPENED TO GET THE DRAIN UNDER LOCAL ANESTHESIA. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19928842 ↗
• InjuryApr 3, 2023Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT A BODYLIFT PROCEDURE ON AND UNKNOWN DATE AND A DRAIN WAS USED. DEVICE DEFECTIVE, LOSS OF THE VACUUM AT THE POST-OP DAY 2. OBSERVATION OF RUPTURE ON THE POST-OP DAY 4, EVEN BEFORE THE ATTEMPT TO REMOVE IT. A SECOND PROCEDURE WAS NEEDED TO REMOVE WITHOUT REPLACING THE DRAIN. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

  Patient problems: Foreign Body In Patient; Scar Tissue

  MAUDE report 16663591 ↗
• MalfunctionMay 23, 2022Break; Break

  IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE AND A DRAIN WAS USED. IN THE PROCESS OF REMOVING THE DRAIN, THIS NURSE CUT THE SECUREMENT STITCH AND STARTED MANIPULATING THE TUBE FOR REMOVAL, THERE WAS DIFFICULTY IN PULLING OUT AND A TEAR DEVELOPED BETWEEN THE FLAT END DRAIN AND THE TUBING. FORCEPS WERE USED TO SECURE THE END FLAT DRAIN. THE RUPTURED DRAIN WAS ABLE TO BE REMOVED COMPLETELY. THE ITEM WAS NOT SAVED AND WAS DISCARDED, THE ITEMS WERE FULLY REMOVED FROM THE PATIENT AND NO HARM CAME TO THE PATIENT AS REPORTED AT THIS TIME. PATIENT RECOVERED COMPLETELY AND WITHOUT FURTHER PROBLEMS. NO REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION WAS REQUESTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14472098 ↗