BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GENTRIX SURGICAL MATRIX THICK

    MDR report key: 9500492 · Received December 20, 2019

    Report

    Report Number
    3005920706-2019-00022
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    November 21, 2019
    Report Date
    December 3, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001561
    PMA / PMN Number
    K170763
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND WAS DISCARDED. SURGEON CHOOSE TO USE AN UNKNOWN, NON-ACELL DEVICE. THE PATIENT DID NOT EXPERIENCE ANY COMPLICATION DUE TO THE SUTURE PULL THROUGH. THE DEVICE WAS NOT 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"11/2119," ACELL, INC. BECAME AWARE THAT SUTURE PULL THROUGH OCCURRED WITH AN ACELL DEVICE DURING AN INCISIONAL HERNIA REPAIR. THE DEVICE WAS NOT USED. THE SURGEON DECIDED TO USE AN UNKNOWN, NON-ACELL DEVICE 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
    1300469 GENTRIX SURGICAL MATRIX THICK GENTRIX SURGICAL MATRIX THICK FTM ACELL, INC. PSMT2030 016398 00386190001561

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR Other