BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PELVIC FLOOR MATRIX

    MDR report key: 8803568 · Received July 18, 2019

    Report

    Report Number
    3005920706-2019-00015
    Event Type
    Injury
    Date Received
    July 18, 2019
    Date of Event
    April 3, 2019
    Report Date
    June 19, 2019
    Manufacturer
    ACELL, INC.
    Product Code
    FTM
    UDI-DI
    00386190001288
    PMA / PMN Number
    K141084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED DUE TO THE STUDY SUBJECT PARTICIPANT REPORTED ADVERSE EVENT (AE) OF RECURRENT PROLAPSE. THERE WAS NO REPORTS OF DEVICE FAILURE AT THE TIME OF INDEX AND FOLLOW UP SURGERY. THE ACELL DEVICE WAS NOT EXPLANTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT IDENTIFIED NO DEVIATIONS IN THE PRODUCTION PROCESS. THE DEVICE WAS MANUFACTURED AND DISTRIBUTED STERILE IN COMPLIANCE WITH FDA, STATE, LOCAL LAWS AND REGULATIONS, AND ACELL'S OPERATING PROCEDURES.

    Description of Event or Problem · 1

    ON 6/19/2019 ACELL, INC. RECEIVED AN ADVERSE EVENT THROUGH THE (B)(6) REGISTRY FROM OUR (B)(6) POSTMARKET SURVEILLANCE STUDIES ON TRANSVAGINAL PELVIC MESH PLACEMENT FOR THE TREATMENT OF PELVIC ORGAN PROLAPSE (POP). DURING THE EVALUATION OF THE ADVERSE EVENT, WE LEARNED THAT THE PRODUCT SOLYX (BOSTON SCIENTIFIC) WAS ALSO INVOLVED IN THE INCIDENT. THE STUDY SUBJECT IS EXPERIENCING CONTINUING RECURRENT PROLAPSE FOLLOWING PELVIC FLOOR REPAIR WITH AN ACELL'S DEVICE AND BOSTON SCIENTIFIC SOLYX PRODUCT. THE INDEX POP REPAIR PROCEDURE WAS CONDUCTED ON (B)(6) 2018 AND THE ADVERSE EVENT ONSET WAS (B)(6) 2019. ADDITIONAL SURGICAL TREATMENT WAS PERFORMED ON (B)(6) 2019. THERE WAS NO PROCEDURAL COMPLICATION AT THE TIME OF INDEX AND FOLLOW UP SURGERY. THE ACELL DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598771 PELVIC FLOOR MATRIX PELVIC FLOOR MATRIX FTM ACELL, INC. PFM0912 PD000965 00386190001288

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other