BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    STRATAFIX SUTURE

    MDR report key: 11700326 · Received April 21, 2021

    Report

    Report Number
    3010692967-2021-00016
    Event Type
    Injury
    Date Received
    April 21, 2021
    Date of Event
    March 16, 2021
    Report Date
    June 2, 2021
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    UDI-DI
    20705031227948
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    TO CLARIFY THAT THE MDR SUBMITTED IS NOT THE SUBJECT OF AN APPROVED EXEMPTION AND THEREFORE NUMBER ¿5645646¿ INCLUDED IN THE ¿EXEMPTION NUMBER¿ FIELD WAS SUBMITTED IN ERROR.¿

    Additional Manufacturer Narrative · 1

    A BATCH REVIEW OF THE FINISHED GOOD LOT AND COMPONENTS CONFIRMED THERE WERE NO QUALITY ISSUES NOTED THROUGHOUT THE INCOMING INSPECTION, MANUFACTURING, STERILIZATION, IN-PROCESS OR FINAL INSPECTION PROCESS. NO SAMPLES OR PHOTOGRAPHS WERE PROVIDED FOR REVIEW OR TESTING. IF STERILE SAMPLES OR PHOTOGRAPHS BECOME AVAILABLE AT A LATER TIME, THE DEVICES AND/OR PHOTOS WILL BE REVIEWED AND/OR TESTED AND THE RESULTS WILL BE INCLUDED IN THE FILE. A FOLLOW-UP REPORT WILL BE SUBMITTED. WITHOUT RECEIVING SAMPLES FROM THE SAME FINISHED GOOD LOT FOR REVIEW OR TESTING OR RECEIVING PERTINENT DETAILS REGARDING PATIENT SPECIFIC INFORMATION (EX. PATIENT HEALTH HISTORY, PAST REACTION TO SUTURE MATERIALS, PREVIOUS HISTORY OF POLYPS) AND THE PROCEDURE PERFORMED, THE SURGEON¿S TECHNIQUE, OR POST-OPERATIVE EVENTS THAT MAY HAVE OCCURRED AND/OR CONTRIBUTED TO THE EVENTS, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT TOTAL HYSTERECTOMY SURGERY ON (B)(6) 2020, AND THE DEVICE WAS USED TO SEW THE VAGINAL STUMP. ON (B)(6) 2021, THE PATIENT WENT BACK TO THE HOSPITAL FOR REEXAMINATION. THROUGH COLPOSCOPY, POLYPS WERE FOUND ON BOTH SIDES OF THE VAGINAL STUMP, THEN THE POLYPS WERE CUT OFF WITH LEEP KNIFE UNDER COLPOSCOPE. THE PATIENT IS STABLE NOW. THE CUSTOMER SUSPECT THAT THE SUTURE REJECTION IS TOO SERIOUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    598573 STRATAFIX SUTURE CT-1 0 PDO 30CM NEW SURGICAL SPECIALTIES SXPD1B401 AAFZ730 20705031227948

    Patients

    Seq Age Sex Outcome Treatment
    1