BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORELLE DIRECTFIX ANTERIOR

    MDR report key: 6185460 · Received December 19, 2016

    Report

    Report Number
    2125050-2016-00385
    Event Type
    Injury
    Date Received
    December 19, 2016
    Report Date
    December 19, 2016
    Manufacturer
    COLOPLAST A/S
    Product Code
    FTL
    PMA / PMN Number
    K103568
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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. SHOULD ADDITIONAL FACTS PROMPT US TO ALTER OR SUPPLEMENT ANY INFORMATION OF CONCLUSIONS CONTAINED IN THE ORIGINAL MDR OR IN ANY PRIOR SUPPLEMENTAL REPORTS, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE AVAILABLE INFORMATION, PROCEDURE WAS PERFORMED WITH A RESTORELLE DIRECTFIX ANTERIOR AND DIGITEX. PATIENT RETURNED ON (B)(6) 2016 WITH A FEVER AND LEFT LOWER QUADRANT ABDOMINAL PAIN. NO VAGINAL DISCHARGE. TEMP 39.5 C (103.1 F), BP 99/51. CT SHOWED HEMATOMA IN PELVIS. SEPSIS. ANTIBIOTICS STARTED. PHYSICIAN FEELS THERE IS A DEFINITE RELATIONSHIP TO THE PROCEDURE, POSSIBLE RELATIONSHIP TO THE DEVICE. PATIENT HOSPITALIZATION (B)(6) 2016. STILL HOSPITALIZED (B)(6) 2016.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838384 RESTORELLE DIRECTFIX ANTERIOR SURGICAL MESH FTL COLOPLAST A/S 5014502400

    Patients

    Seq Age Sex Outcome Treatment
    1 Other