BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTA AH

    MDR report key: 24307420 · Received February 10, 2026

    Report

    Report Number
    1213643-2026-00101
    Event Type
    Injury
    Date Received
    February 10, 2026
    Date of Event
    September 1, 2024
    Report Date
    January 22, 2026
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    LMG
    PMA / PMN Number
    P050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE CONTENTS OF THE ARTICLE, NO CONCLUSIONS CAN BE MADE. THE INFORMATION PROVIDED IN THE ARTICLE INDICATES THAT SOME PATIENTS EXPERIENCED POST OPERATIVE COMPLICATIONS. THE INFORMATION OBTAINED IS LIMITED TO THE CONTENT OF THE ARTICLE. THE ARTICLE DOES NOT REPORT ANY SPECIFIC DEVICE MALFUNCTION OR POST-OP COMPLICATIONS WERE CAUSED OR CONTRIBUTED TO THE USE OF THE ARISTA AH. HEMORRHAGE IS KNOWN INHERENT RISKS OF SURGERY AND IS LISTED IN THE ADVERSE REACTIONS SECTION OF THE INSTRUCTIONS-FOR-USE, SUPPLIED WITH THE DEVICE AS POSSIBLE COMPLICATIONS. NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-SEP-2024) IS CONSIDERED TO BE A BEST ESTIMATE. NOTE: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "CLINICAL EVALUATION OF THE HEMOSTATIC EFFICACY AND SAFETY OF A BIODEGRADABLE HEMOSTATIC AGENT, HEMOGRAM: A COMPARATIVE STUDY WITH ARISTA AH." THIS RANDOMIZED, CONTROLLED TRIAL EVALUATED THE CLINICAL EFFICACY AND SAFETY OF HEMOGRAM COMPARED WITH THE COMMERCIALLY AVAILABLE AGENT ARISTA AH WHO UNDERWENT GASTRIC CANCER SURGERY. THE CLINICAL TRIAL WAS CONDUCTED BETWEEN SEPTEMBER 2024 AND MAY 2025. 64 PATIENTS WERE EVENLY RANDOMIZED TO RECEIVE EITHER HEMOGRAM (N = 32) OR ARISTA AH (N = 32) FOR LOCAL HEMOSTASIS. HEMOSTATIC SUCCESS WITHIN 5 MIN WAS ACHIEVED IN 100% (32/32) OF THE HEMOGRAM GROUP AND 96.9% (31/32) OF THE ARISTA AH GROUP, WITH NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE TWO (P > 0.05). THE MEAN TIME TO HEMOSTASIS WAS 1.25 ± 0.80 MIN IN THE HEMOGRAM GROUP AND 1.52 ± 0.85 MIN IN THE ARISTA AH GROUP. THE POSTOPERATIVE COMPLICATIONS OF ARISTA AH INCLUDE LEAKAGE, INTRA ABDOMINAL ABSCESS, CARDIAC PROBLEM AND DELAYED GASTRIC EMPTYING AND BLEEDING. THE ARTICLE CONCLUDES THAT THE FINDINGS OF THIS STUDY NO RE-BLEEDING EVENTS WERE OBSERVED IN THE HEMOGRAM GROUP, WHILE ONE CASE OF RE-BLEEDING (3.3%) WAS REPORTED IN THE ARISTA AH GROUP. THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN GROUPS IN TERMS OF TRANSFUSION VOLUME, LENGTH OF HOSPITALIZATION, OR ADVERSE EVENT RATES. HEMOGRAM DEMONSTRATED NON-INFERIOR HEMOSTATIC EFFICACY AND SAFETY COMPARED TO ARISTA AH IN PATIENTS UNDERGOING GASTRECTOMY. HEMOGRAM ACHIEVED A 100% HEMOSTATIC SUCCESS RATE WITHIN 5 MIN, WITH NO PRODUCT-RELATED ADVERSE EVENTS REPORTED, SUPPORTING BOTH ITS SAFETY AND CLINICAL UTILITY. NOTE: THERE IS NO INFORMATION PROVIDED IN THE ARTICLE INDICATING THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE POSTOPERATIVE PATIENT COMPLICATION(S). HOWEVER, AS POSTOPERATIVE COMPLICATIONS DID PRESENT AND SOME REQUIRING MEDICAL/SURGICAL INTERVENTION WE ARE REPORTING THIS AS A SERIOUS INJURY MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363604 ARISTA AH AGENT, ABSORBABLE HEMOSTATIC, COLLAGEN BASED LMG DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other