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HEMOBLAST Bellows BQF02Recalls & reported problems

Dilon Technologies France · Hemostatic agent, including thrombin · Class 3 · Implant

Adverse event reports
3
Deaths reported
0
Injuries reported
3
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03760193182705), received between Jul 11, 2019 and Jul 26, 2021 — classified as 3 injuries.

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

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Improper or Incorrect Procedure or Method1
  • Patient-Device Incompatibility1

Patient problems

  • Hematoma2
  • Seroma1

Recent adverse event reports

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

  • InjuryJul 26, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

    TWO DAYS AFTER BREAST RECONSTRUCTION SURGERY, PATIENT WAS BROUGHT BACK TO OR TO EVACUATE A 400CC SEROMA. SEROMA FORMATION WAS ATTRIBUTED TO CLOGGED DRAIN. SURGEON REPORTED THE DRAIN WAS CLOGGED FROM THE HEMOBLAST.

    Patient problems: Seroma

    MAUDE report 12224555 ↗
  • InjuryJul 11, 2019Patient-Device Incompatibility

    SURGEON REPORTED THAT A SMALL HEMATOMA HAD FORMED ON THE RIGHT SIDE OF A MALE PATIENT'S FACE FOLLOWING A FACELIFT IN WHICH HEMOBLAST¿ BELLOWS WAS USED. THE DRAIN WAS NOTED TO BE PLACED SUPERIOR TO THE HEMATOMA. THE HEMATOMA WAS IDENTIFIED THE DAY AFTER SURGERY, IN A SPOT SUPERIOR TO THE DRAIN NEAR THE EAR. THE SURGEON EVACUATED 1-2 MLS OF BLOOD FROM THE AREA.

    Patient problems: Hematoma

    MAUDE report 8781832 ↗
  • InjuryJul 11, 2019Adverse Event Without Identified Device or Use Problem

    PHYSICIAN PERFORMED CAPSULECTOMY AND REMOVED SUBPECTOL BREAST IMPLANT. HEMOBLAST BELLOWS WAS APPLIED OVER MUSCLE, ESPECIALLY IN AXILLARY REGION. THE AREA WAS OBSERVED TO BE DRY WHEN SKIN WAS CLOSED. WITHIN 7 HOURS POST-OP THE PATIENT HAD SWELLING ON LEFT SIDE. PATIENT WAS RETURNED TO OPERATING ROOM AND 500 - 1000 ML BLOOD WAS EVACUATED.

    Patient problems: Hematoma

    MAUDE report 8781502 ↗

Other Absorbable Collagen Hemostatic Agent With Thrombin devices

All Absorbable Collagen Hemostatic Agent With Thrombin devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.