BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX PLUS

    MDR report key: 8297540 · Received February 1, 2019

    Report

    Report Number
    3005920706-2019-00001
    Event Type
    Injury
    Date Received
    February 1, 2019
    Date of Event
    October 18, 2018
    Report Date
    January 10, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001240
    PMA / PMN Number
    K162554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING. ACELL CONDUCTED STERILITY TESTING ON THE SAME RETAINED LOT, RESULTS INDICATED NO GROWTH WAS OBSERVED. THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED INFECTION AFTER INITIAL PLACEMENT OF THE ACELL DEVICE IN CONJUNCTION WITH A KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM. 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 FDA, STATE, LOCAL, AND ACELL'S OPERATING PROCEDURES. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF INITIAL SURGERY.

    Description of Event or Problem · 0

    ON 1/3/19, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN INFECTION AFTER APPLICATION OF AN ACELL DEVICE AND USAGE OF KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM. THE SURGEON CONDUCTED A COLOSTOMY REVERSAL AND PARASTOMAL HERNIA REPAIR ON (B)(6) 2018, AN ACELL DEVICE WAS PLACED IN AN UNDERLAY TECHNIQUE AND THE FASCIA RE-APPROXIMATED. THE SKIN WAS LEFT OPEN WITH KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM APPLIED TO THE AREA. DURING THE FIRST WOUND VACUUM CHANGE, AN INFECTION WAS DISCOVERED. THE SURGEON IS UNSURE IF THE DEVICE WAS THE CAUSE THE INFECTION. THE SURGEON PERFORMED A POST-OPERATIVE WASHOUT AND DEBRIDEMENT INCLUDING THE EXPLANTING OF THE ACELL DEVICE. THERE WAS NO DATE PROVIDED OF WHEN THIS PROCEDURE WAS CONDUCTED.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED INFECTION AFTER INITIAL PLACEMENT OF THE ACELL DEVICE IN CONJUNCTION WITH A KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM. 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 FDA, STATE, LOCAL, AND ACELL'S OPERATING PROCEDURES. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF INITIAL SURGERY. WE ARE SUBMITTING THIS REPORT NOW, WITHOUT RESULTS OF STERILITY TESTING, IN ORDER TO SUBMIT A TIMELY REPORT AND WILL PROVIDE A FOLLOW-UP UPON COMPLETION OF STERILITY TESTING.

    Description of Event or Problem · 1

    ON 1/3/2019, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN INFECTION AFTER APPLICATION OF AN ACELL DEVICE AND USAGE OF KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM. THE SURGEON CONDUCTED A COLOSTOMY REVERSAL AND PARASTOMAL HERNIA REPAIR ON (B)(6) 2018, AN ACELL DEVICE WAS PLACED IN AN UNDERLAY TECHNIQUE AND THE FASCIA RE-APPROXIMATED. THE SKIN WAS LEFT OPEN WITH KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM APPLIED TO THE AREA. DURING THE FIRST WOUND VACUUM CHANGE, AN INFECTION WAS DISCOVERED. THE SURGEON IS UNSURE IF THE DEVICE WAS THE CAUSE THE INFECTION. THE SURGEON PERFORMED A POST-OPERATIVE WASHOUT AND DEBRIDEMENT INCLUDING THE EXPLANTING OF THE ACELL DEVICE. THERE WAS NO DATE PROVIDED OF WHEN THIS PROCEDURE WAS CONDUCTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89886 GENTRIX SURGICAL MATRIX PLUS GENTRIX SURGICAL MATRIX PLUS FTM ACELL, INC. MSPL1015 013211 00386190001240

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM| KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM| KCI (ACELITY) PREVENA NEGATIVE PRESSURE SYSTEM