BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 17035100 · Received May 31, 2023

    Report

    Report Number
    1000306051-2023-00116
    Event Type
    Injury
    Date Received
    May 31, 2023
    Report Date
    May 31, 2023
    Manufacturer
    LIFECELL
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRESPONDING AUTHOR AND ASSOCIATED INSTITUTION. THIS MDR IS BEING REPORTED AS AN INDIVIDUAL EVENT TYPE FOR SERIOUS INJURY DUE TO THE ASSUMED INTERVENTION TO TREAT THE COMPLICATIONS OF INFECTION, REHERNIATION AND WOUND DEHISCENCE. MULTIPLE ATTEMPTS ARE BEING MADE TO CONTACT THE CORRESPONDING AUTHOR TO GATHER ADDITIONAL PATIENT AND PROCEDURE SPECIFIC INFORMATION INCLUDING LOT NUMBERS AND DEVICE DISPOSITIONS. TO DATE, THE LOT NUMBERS ASSOCIATED WITH THESE EVENTS REMAIN UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. BASED ON THE REPORTED INFORMATION, A RELATIONSHIP BETWEEN THE EVENTS AND THE STRATTICE DEVICES CANNOT BE DETERMINED. AS PER THE IFU, POTENTIAL ADVERSE EVENTS ARE THOSE TYPICALLY ASSOCIATED WITH SURGICAL MESH MATERIALS AND/OR THEIR IMPLANTATION PROCEDURES INCLUDING, BUT NOT LIMITED TO, INFECTION, RECURRENCE AND WOUND DEHISCENCE. NO FURTHER ACTIONS ARE REQUIRED AS A NONCONFORMANCE COULD NOT BE CONFIRMED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    DURING A LITERATURE VIEW PERFORMED BY PATIENT SAFETY OPERATIONS ON (B)(6) 2023, AN ARTICLE TITLED "PREOPERATIVE BOTULINUM TOXIN A (BTA) INJECTION VERSUS COMPONENT SEPARATION TECHNIQUES (CST) IN COMPLEX ABDOMINAL WALL RECONSTRUCTION (AWR): A PROPENSITY-SCORED MATCHED STUDY" WAS IDENTIFIED WHICH DISCUSSED A PROSPECTIVE, SINGLE-CENTER, STUDY OF PATIENTS UNDERGOING OPEN ABDOMINAL WALL RECONSTRUCTION FROM 2016 TO 2021 WITH BOTULINUM TOXIN A VERSUS COMPONENT SEPARATION TECHNIQUES WAS PERFORMED BASED ON BODY MASS INDEX, DEFECT WIDTH, HERNIA VOLUME, AND CENTERS FOR DISEASE CONTROL AND PREVENTION WOUND CLASSIFICATION. MATCHED PATIENTS INCLUDED 105 COMPONENT SEPARATION TECHNIQUES AND 35 BOTULINUM TOXIN A. THERE WAS NO DIFFERENCE IN TOBACCO USE, DIABETES, OR BODY MASS INDEX. HERNIA DEFECTS AND VOLUME WERE LARGE FOR BOTH THE COMPONENT SEPARATION TECHNIQUES AND BOTULINUM TOXIN A GROUPS. CENTERS FOR DISEASE CONTROL AND PREVENTION WOUND CLASSIFICATIONS WERE EQUIVALENT. COMPONENT SEPARATION TECHNIQUES WERE MORE FREQUENTLY PERFORMED IN EUROPEAN HERNIA SOCIETY M1 HERNIAS. THE BOTULINUM TOXIN A GROUP HAD FEWER SURGICAL SITE OCCURRENCES AND SURGICAL SITE INFECTIONS. IN MULTIVARIATE ANALYSIS, BOTULINUM TOXIN A WAS ASSOCIATED WITH LOWER RATES OF SURGICAL SITE OCCURRENCES. THERE WAS NO DIFFERENCE IN FASCIAL CLOSURE OR RECURRENCE. THE OVERALL CONCLUSION REPORTED THAT IN A MATCHED STUDY COMPARING PATIENTS WITH BOTULINUM TOXIN A VERSUS COMPONENT SEPARATION TECHNIQUES, THERE WAS NO DIFFERENCE IN FASCIAL CLOSURE RATES OR IN HERNIA RECURRENCE BETWEEN THE 2 GROUPS. PREOPERATIVE BOTULINUM TOXIN A CAN ACHIEVE SIMILAR OUTCOMES AS COMPONENT SEPARATION TECHNIQUES, WHILE DECREASING THE FREQUENCY OF SURGICAL SITE OCCURRENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1296973 UNKNOWN STRATTICE MESH, SURGICAL FTM LIFECELL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention NO INFORMATION REPORTED