BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 23303952 · Received October 15, 2025

    Report

    Report Number
    2210968-2025-11906
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    May 30, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. 1. WHAT WAS THE DATE OF THE PROCEDURE? 2. WHAT IS THE NAME OF THE PROCEDURE? 3. WHAT WAS THE INDICATION FOR USING THE PRODUCT? 4. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? 5. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 6. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 7. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 8. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? 9. WHAT IS THE CURRENT CONDITION OF THE PATIENT? CITATION: DOI: 10.25259/SNI_125_2025. PMID: 40469340; PMCID: PMC12134848. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: KALAI F, FATEN O, BEN BRAHEM S, ARDHAOUI I, REBAI L. POSTOPERATIVE FIBRINOGEN DEFICIENCY AFTER SURGICAL REMOVAL OF INTRACRANIAL TUMORS: PREVALENCE, RISK FACTORS AND PROGNOSIS. SURG NEUROL INT. 2025 MAY 30;16:204. DOI: 10.25259/SNI_125_2025. PMID: 40469340; PMCID: PMC12134848. THE AIM OF THIS MONOCENTRIC, PROSPECTIVE, DESCRIPTIVE AND ANALYTICAL STUDY WAS TO STUDY THE PREVALENCE OF HYPOFIBRINOGENEMIA POST BRAIN TUMOR RESECTION, TO IDENTIFY THE RISK FACTORS FOR THIS ANOMALY, AND TO HELP THE PRACTITIONER PREVENT IT IN ORDER TO REDUCE THE RISK OF ITS POTENTIALLY SERIOUS COMPLICATIONS. DURING THE STUDY PERIOD, A TOTAL OF 120 PATIENTS (57 MALE AND 63 FEMALE; MEAN AGE WAS 51 ± 14 YEARS) WHO UNDERWENT UNDERWENT SURGERY FOR INTRACRANIAL TUMORS WERE INCLUDED IN THE STUDY. INTRAOPERATIVE BLEEDING WAS ESTIMATED BY QUANTIFYING BLOOD IN A SUCTION BOTTLE AND WEIGHING COMPRESSES AND DRAPES. ANY HEMOSTATIC PRODUCTS USED (ABSORBABLE HEMOSTATIC COMPRESSES [SURGICEL, FIBRILLAR SURGICEL] AND HEMOSTATIC GEL [SURGIFLO]) WERE NOTED. FLUID THERAPY CONSISTS OF THE ADMINISTRATION OF ISOTONIC CRYSTALLOIDS AND COLLOIDS GUIDED BY MONITORING MEAN ARTERIAL PRESSURE AND URINE OUTPUT. PERIOPERATIVE TRANSFUSION TRIGGER FOR RED BLOOD CELLS WAS A HEMOGLOBIN CONCENTRATION <8 G/DL. FRESH FROZEN PLASMA WAS TRANSFUSED AT PT <60%, AND PLATELET CONCENTRATE WAS TRANSFUSED AT PLATELET COUNT <100,000/MM3. REPORTED COMPLICATIONS INCLUDE SURGICEL - HEMOGLOBIN CONCENTRATION <8 G/DL (N=6) TREATMENT: REQUIRED RED BLOOD CELLS TRANSFUSION - FIBRINOGEN DEFICIENCY (N=42) TREATMENT: NOT REPORTED - INTRACRANIAL HEMATOMA (N=18) TREATMENT: NOT REPORTED - NEUROMENINGEAL INFECTION (N=15) TREATMENT: NOT REPORTED - SENSORY-MOTOR DEFICIT (N=27) TREATMENT: NOT REPORTED - OTHER INFECTIONS (N=6) TREATMENT: NOT REPORTED THROMBOTIC COMPLICATIONS (N=3) TREATMENT: NOT REPORTED FIBRILLAR SURGICEL, HEMOGLOBIN CONCENTRATION <8 G/DL (N=6), TREATMENT: REQUIRED RED BLOOD CELLS TRANSFUSION. FIBRINOGEN DEFICIENCY (N=15) TREATMENT: NOT REPORTED. INTRACRANIAL HEMATOMA (N=18) TREATMENT: NOT REPORTED. NEUROMENINGEAL INFECTION (N=15) TREATMENT: NOT REPORTED. SENSORY-MOTOR DEFICIT (N=27) TREATMENT: NOT REPORTED. OTHER INFECTIONS (N=6) TREATMENT: NOT REPORTED. THROMBOTIC COMPLICATIONS (N=3) TREATMENT: NOT REPORTED. SURGIFLO HEMOGLOBIN CONCENTRATION <8 G/DL (N=3) TREATMENT: REQUIRED RED BLOOD CELLS TRANSFUSION. INTRACRANIAL HEMATOMA (N=18) TREATMENT: NOT REPORTED. NEUROMENINGEAL INFECTION (N=15) TREATMENT: NOT REPORTED. SENSORY-MOTOR DEFICIT (N=27) TREATMENT: NOT REPORTED. OTHER INFECTIONS (N=6) TREATMENT: NOT REPORTED. THROMBOTIC COMPLICATIONS (N=3) TREATMENT: NOT REPORTED. IN CONCLUSION, THIS STUDY HIGHLIGHTED THE ROLE OF HYPOFIBRINOGENEMIA IN THE OCCURRENCE OF POSTOPERATIVE BLEEDING AFTER INTRACRANIAL TUMOR SURGERY. WE THEREFORE RECOMMEND SYSTEMATIC POSTOPERATIVE FIBRINOGEN DOSING, ESPECIALLY FOR AT-RISK PATIENTS, TO ENABLE EARLY DETECTION AND TREATMENT OF THIS ABNORMALITY AND TO PREVENT ITS POTENTIALLY SERIOUS COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2357934 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention