BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX PLUS

    MDR report key: 9538229 · Received January 2, 2020

    Report

    Report Number
    3005920706-2019-00023
    Event Type
    Injury
    Date Received
    January 2, 2020
    Date of Event
    December 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001226
    PMA / PMN Number
    K182259
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED OBSTRUCTION THAT OCCURRED AFTER THE INITIAL PLACEMENT OF THE ACELL DEVICE. THE ACELL DEVICE WAS EXPLANTED; HOWEVER IT IS NOT AVAILABLE FOR EVALUATION. 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. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. AN UPDATE "WLLL" BE PROVIDED UPON "RECIEPT" OF MORE INFORMATION.

    Description of Event or Problem · 1

    ON 12/6/19, ACELL, INC. BECAME AWARE THAT AN ACELL DEVICE WAS EXPLANTED DUE TO A BOWEL OBSTRUCTION. THE ACELL DEVICE WAS IMPLANTED (B)(6) 2019 AND EXPLANTED ON (B)(6) 2019. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, ADDITIONAL INFORMATION HAS BEEN REQUESTED. AN UPDATE "WLLL" BE PROVIDED UPON RECIEPT OF MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980 GENTRIX SURGICAL MATRIX PLUS GENTRIX SURGICAL MATRIX PLUS FTM ACELL, INC. MSPL0507 014594 00386190001226

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Required Intervention