BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX THIN

    MDR report key: 8745294 · Received June 28, 2019

    Report

    Report Number
    3005920706-2019-00013
    Event Type
    Injury
    Date Received
    June 28, 2019
    Report Date
    June 1, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K162554
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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. THE PHYSICIAN WAS UNABLE TO PROVIDE FURTHER INFORMATION REGARDING THE ISSUE IN SUBSEQUENT FOLLOW-UP CONVERSATIONS. THE INITIAL MDR WAS SUBMITTED DUE TO THE REPORTED ANASTOMOTIC LEAK AFTER INITIAL PLACEMENT OF THE ACELL DEVICE . THE ACELL DEVICE WAS EXPLANTED; HOWEVER IT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE ACELL DEVICE, LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. ACELL'S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    THIS IS A FOLLOW-UP REPORT FOR ADDITIONAL AND CORRECTED INFORMATION THAT WAS RECEIVED SUBSEQUENT TO THE INITIAL FILING. ON (B)(6) 2019, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN ANASTOMOTIC LEAK AND BECAME SEPTIC, FOUR (4) TO FIVE (5) DAYS AFTER PERFOMING AN ANASTAMOSIS REPAIR WRAPPED WITH AN ACELL GENTRIX DEVICE IN 2014. THE PHYSICIAN WAS UNABLE TO PROVIDE THE DATE OF THE SURGERY AND DEVICE LOT AND SERIAL NUMBER. THE PHYSICIAN STATED HE DOES NOT ATTRIBUTE THE IMPLANTED ACELL DEVICE TO THE ANASTOMOTIC LEAK. THE PHYSICIAN REPAIRED THE LEAK, HOWEVER, THE PATIENT DEVELOPED A BOWEL OBSTRUCTION SIX (6) TO SEVEN (7) MONTHS LATER.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED ANASTOMOTIC LEAK AFTER INITIAL PLACEMENT OF THE ACELL DEVICE. THE ACELL DEVICE WAS EXPLANTED; HOWEVER IT IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE ACELL DEVICE, LOT AND SERIAL NUMBER WAS NOT PROVIDED BY THE SURGEON. NEVERTHELESS, ALL ACELL DEVICES ARE MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, THE INVESTIGATION IS ONGOING AND MORE INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2019, ACELL, INC. WAS NOTIFIED BY A PHYSICIAN THAT THEIR PATIENT DEVELOPED AN ANASTOMOTIC LEAK AND BECAME SEPTIC, FOUR (4) DAYS AFTER PERFORMING AN ANASTAMOSIS REPAIR WRAPPED WITH AN ACELL GENTRIX DEVICE. THE SURGEON WAS UNABLE TO PROVIDE THE DATE OF THE SURGERY AND THE ACELL DEVICE USED. WE ARE SUBMITTING THIS REPORT NOW, HOWEVER, THE INVESTIGATION IS ONGOING AND MORE INFORMATION WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539564 GENTRIX SURGICAL MATRIX THIN GENTRIX SURGICAL MATRIX THIN FTM ACELL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention