BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTRIX SURGICAL MATRIX PLUS

    MDR report key: 8659456 · Received May 31, 2019

    Report

    Report Number
    3005920706-2019-00010
    Event Type
    Malfunction
    Date Received
    May 31, 2019
    Date of Event
    May 2, 2019
    Report Date
    May 2, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001226
    PMA / PMN Number
    K182259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED SUTURE PULL THROUGH THAT OCCURRED DURING THE INITIAL PLACEMENT OF THE ACELL DEVICE. THE DEVICE WAS NOT USED, THE SURGEON DECIDED TO CLOSE THE HERNIA PRIMARILY WHICH RESULTED IN A DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH. THE DEVICE WAS RETURNED TO ACELL FOR FURTHER INVESTIGATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS THAT FALL OUTSIDE OF SPECIFICATION. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH ACELL'S OPERATING PROCEDURES AND FEDERAL, STATE, AND LOCAL LAWS AND REGULATIONS.

    Description of Event or Problem · 1

    ON (B)(4) 2019, ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING THE REINFORCEMENT OF A UMBILICAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO CLOSE THE HERNIA PRIMARILY WHICH RESULTED IN A SURGICAL DELAY (INCREASED SURGERY TIME). THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH NOR THE INCREASED SURGERY TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453209 GENTRIX SURGICAL MATRIX PLUS GENTRIX SURGICAL MATRIX PLUS FTM ACELL, INC. MSPL0507 013335 00386190001226

    Patients

    Seq Age Sex Outcome Treatment
    1 Other