BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX POSTERIOR

    MDR report key: 7488437 · Received May 4, 2018

    Report

    Report Number
    2125050-2018-00344
    Event Type
    Injury
    Date Received
    May 4, 2018
    Date of Event
    November 11, 2016
    Report Date
    June 7, 2018
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP WAS CREATED FOR THE CONCLUSION OF THE INVESTIGATION. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE BENEFIT OF ANALYZING THE EXPLANT, QUALITY CANNOT CONFIRM ANY OBSERVATIONS AND CANNOT COMMENT ON THE CONDITION OF THE PROSTHESIS. THE ROOT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME. IF THE EXPLANTED DEVICE BECOMES AVAILABLE, OR ADDITIONAL INFORMATION IS RECEIVED, QUALITY WILL RE-EVALUATE THIS COMPLAINT IN ACCORDANCE TO PROCEDURES. HOWEVER, BECAUSE QUALITY'S EXAMINATION OF THE AVAILABLE INFORMATION MAY NOT CONCLUSIVELY CONFIRM OR DISPROVE THE REPORT OF EXPOSURE, QUALITY ACCEPTS THE PHYSICIAN'S OBSERVATIONS OF SUCH AS THE REASON FOR SURGICAL INTERVENTION. THIS COMPLAINT WAS FORWARDED TO THE CONTRACT MANUFACTURER (CM) FOR REVIEW. THE RESULTS OF THE CM INVESTIGATION INDICATED THAT THERE HAVE BEEN THREE PREVIOUS COMPLAINTS RELATED TO LOT NUMBER 4944756 FOR VAGINAL WALL PROLAPSE, UNSPECIFIED PELVIC PAIN, AND VAGINAL DISCHARGE. THE KNIT BATCH (K0218) AND THE LOT ITSELF BOTH PASSED ALL REQUIRED TESTING. MANAGEMENT ROUTINELY REVIEWS EVENTS SUCH AS THIS AND MONITORS COMPLAINT LEVELS. ADDITIONALLY, EVENTS OF THIS TYPE ARE CAPTURED IN THE PRODUCT RISK DOCUMENTATION. BASED ON THIS INFORMATION, NO FURTHER CORRECTIVE ACTION IS REQUIRED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    WITHOUT THE BENEFIT OF EXAMINATION AND TESTING, COLOPLAST IS PRECLUDED FROM COMMENTING ON THE CONDITION OF THE DEVICE OR THE CAUSE OF THE OCCURRENCE. ONCE OUR EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, MESH EXPOSURE IN VAGINA. SUBJECT WAS INITIALLY TREATED CONSERVATIVELY FOR MESH EXPOSURE BY MESH TRIMMING, BUT SUBSEQUENTLY EXPERIENCED MULTIPLE CONCOMITANT EVENTS OVER NEXT 4 MONTHS, RESULTING IN SAE FOR INPATIENT HOSPITALIZATION AND PARTIAL EXPLANT OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328891 RESTORELLE DIRECTFIX POSTERIOR SURGICAL MESH FTL COLOPLAST A/S 5014602400 4944756

    Patients

    Seq Age Sex Outcome Treatment
    1 Other