BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARISTA AH

    MDR report key: 18184801 · Received November 21, 2023

    Report

    Report Number
    1213643-2023-00450
    Event Type
    Injury
    Date Received
    November 21, 2023
    Date of Event
    April 1, 2018
    Report Date
    November 6, 2023
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC. -1213643
    Product Code
    LMG
    UDI-DI
    00801741044106
    PMA / PMN Number
    P050038
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 IS LIMITED TO THE ARTICLE. THE JOURNAL ARTICLE DID NOT INCLUDE ANY ANALYSIS OF HOW OR IF THE ARISTA AH POTENTIALLY CAUSED OR CONTRIBUTED TO ANY PATIENT OUTCOME OR COMPLICATIONS. SEROMA, HEMATOMA, INFECTION ARE KNOWN INHERENT RISKS OF THE SURGERY AND ADVERSE EVENT AS IDENTIFIED IN THE IFU INCLUDED WITH THE PRODUCT. IN REGARDS TO INFECTION, THE WARNINGS SECTION OF THE IFU STATES, "ARISTA¿ AH SHOULD BE USED WITH CAUTION IN THE PRESENCE OF INFECTION OR IN CONTAMINATED AREAS OF THE BODY. IF SIGNS OF INFECTION OR ABSCESS DEVELOP WHERE ARISTA¿ AH HAS BEEN APPLIED, RE-OPERATION MAY BE NECESSARY IN ORDER TO ALLOW DRAINAGE." NO LOT NUMBER HAS BEEN PROVIDED; THEREFORE, A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE. NOTE, THE DATE OF EVENT (01-APR-2018) IS PROVIDED AS AN ESTIMATE BASED ON THE INFORMATION PROVIDED. 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. H3 OTHER TEXT : NOT RETURNED.

    Description of Event or Problem · 0

    PER JOURNAL ARTICLE: "EFFECT OF MICROPOROUS POLYSACCHARIDE HEMOSPHERES ON ANTEROLATERAL THIGH FREE FLAP DONOR SITE COMPLICATIONS." THE AIM OF THE STUDY WAS TO DETERMINE IF THE APPLICATION OF MPH (ARISTA AH) DURING CLOSURE OF THE ALT DONOR SITE REDUCES POSTOPERATIVE DRAIN OUTPUTS AS WELL AS SEROMA OR HEMATOMA FORMATION. THIS STUDY DESCRIBES PROSPECTIVE, SINGLE-BLIND, RANDOMIZED CONTROLLED TRIAL OF PATIENTS UNDERGOING FASCIOCUTANEOUS ALT HARVEST FOR HEAD AND NECK RECONSTRUCTION AT A TERTIARY ACADEMIC MEDICAL CENTER BETWEEN APRIL 2018 AND FEBRUARY 2020. 62 PATIENTS WERE ENROLLED IN THE STUDY WHICH INCLUDES 34 PATIENTS TO THE INTERVENTION GROUP AND 28 TO THE CONTROL GROUP. IN TOTAL, 55 PATIENTS WERE ANALYZED AND NOTED THAT 29 PATIENTS IN THE INTERVENTION GROUP (MPH) AND 26 PATIENTS IN THE CONTROL GROUP (NO-MPH). THE INTERVENTION GROUP RECEIVED A 3 G DOSE OF MPH (ARISTA AH). IN MPH GROUP, THE MEAN DRAIN OUTPUT WAS 284.7 ± 153.0 ML, AND THE SURGICAL DRAINS WERE REMOVED AFTER A MEAN OF 5.9 ± 1.5 DAYS. WITHIN 6 MONTHS POSTOPERATIVELY, PATIENT HAD SEROMA (6), HEMATOMA (2) AND DONOR SITE INFECTION (2). THERE WAS NO SIGNIFICANT DIFFERENCE IN SEROMA, HEMATOMA, OR INFECTION. DRAIN OUTPUT WAS NOT SIGNIFICANTLY INFLUENCED BY GENDER, AGE, BODY WEIGHT OR SMOKING HABITS. THE STUDY CONCLUDED THAT THE MICROPOROUS POLYSACCHARIDE HEMOSPHERES ADMINISTRATION TO ANTEROLATERAL THIGH FREE FLAP DID NOT SIGNIFICANTLY IMPROVE DRAIN OUTPUT, HEMATOMA FORMATION, OR SEROMA FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722537 ARISTA AH AGENT, ABSORBABLE HEMOSTATIC, NON COLLAGEN BASED LMG DAVOL INC., SUB. C.R. BARD, INC. -1213643 NA NI 00801741044106

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention