BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENTRIX SURGICAL MATRIX

    MDR report key: 8552542 · Received April 25, 2019

    Report

    Report Number
    3005920706-2019-00005
    Event Type
    Injury
    Date Received
    April 25, 2019
    Date of Event
    December 6, 2018
    Report Date
    March 18, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    PMA / PMN Number
    K182259
    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. ACELL RECIEVED INFORMATION ON 5/20/19 REGARDING THE DATE OF INITIAL SURGERY PERFORMED AND ACELL DEVICE USED. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF INITIAL SURGERY. THE DEVICE 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. ACELL'S INVESTIGATION IS COMPLETE. INITIAL FILING - THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED DYSPHAGIA WHICH RESULTED IN EXPLANTATION OF THE ACELL DEVICE. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS THE CAUSE OF THE REPORTED SYMPTOM. THE ACELL DEVICE WAS EXPLANTED, HOWEVER, IT IS NOT AVAILABLE FOR EVALUATION. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE 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.

    Description of Event or Problem · 0

    ON 3/18/19, ACELL, INC. WAS NOTIFIED THAT A PATIENT EXPERIENCED DYSPHAGIA AFTER IMPLANTATION OF A ACELL DEVICE FOR A HIATAL HERNIA REPAIR SIX (6) WEEKS POST-OPERATIVE. THE DATE OF IMPLANTATION IS UNKNOWN. THE SURGEON STATED HE EXPLANTED THE ACELL DEVICE DUE TO THE PATIENT EXPERIENCING DYSPHAGIA. THE DATE OF EXPLANTATION IS UNKNOWN. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS RELATED TO THE SYMPTOMS THE PATIENT REPORTED, NEVERTHELESS, IS SATISFIED WITH THE OUTCOME OF THE PATIENT.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE REPORTED DYSPHAGIA WHICH RESULTED IN EXPLANTATION OF THE ACELL DEVICE. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS THE CAUSE OF THE REPORTED SYMPTOM. THE ACELL DEVICE WAS EXPLANTED, HOWEVER, IT IS NOT AVAILABLE FOR EVALUATION. THE SURGEON IS SATISFIED WITH THE OUTCOME OF THE PATIENT. A REVIEW OF THE MANUFACTURING RECORDS IS NOT POSSIBLE AS THE 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. THERE WERE NO REPORTS OF DEVICE FAILURE AT THE TIME OF INITIAL SURGERY. 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 THAT A PATIENT EXPERIENCED DYSPHAGIA AFTER IMPLANTATION OF A ACELL DEVICE FOR A HIATAL HERNIA REPAIR SIX (6) WEEKS POST-OPERATIVE. THE DATE OF IMPLANTATION IS UNKNOWN. THE SURGEON STATED HE EXPLANTED THE ACELL DEVICE DUE TO THE PATIENT EXPERIENCING DYSPHAGIA. THE DATE OF EXPLANTATION IS UNKNOWN. THE SURGEON CANNOT CONFIRM THAT THE ACELL DEVICE WAS RELATED TO THE SYMPTOMS THE PATIENT REPORTED, NEVERTHELESS, IS SATISFIED WITH THE OUTCOME OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341087 GENTRIX SURGICAL MATRIX GENTRIX SURGICAL MATRIX FTM ACELL, INC. PSMX0710 JD001599

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other