BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4017198 · Received July 31, 2014

    Report

    Report Number
    3008845715-2014-00029
    Event Type
    Other
    Date Received
    July 31, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 30, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    K051609
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. NO PRODUCT EVAL CAN BE PERFORMED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES PUERTO RICO INC REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE CAN NOT BE DETERMINED WITH CERTAINTY BASED ON THE INFO PROVIDED. REFERENCE: COMPLAINT (B)(4); ITEM #SXPD2B409 STRATAFIX SPIRAL PDO KNOTLESS TISUE CONTROL DEVICE. 2FS-2 3-0 UNDYD MONODERM 30X30, LOT: BSF530.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, THE PT GOT A LAPAROSCOPIC TOTAL HYSTERECTOMY + RIGHT ADNEXECTOMY. THERE WAS ABDONIMAL VAGINAL BLEEDING 14 DAYS AFTER THIS INITIAL SURGERY. PT EXAMINATION REVEALED A VAGINAL CUFF DEHISCENCE. VAGINAL CUFF WAS CLOSED VIA VAGINAL ROUTE." PT WAS HOSPITALIZED AND REQUIRED ADD'L PROCEDURES. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448490 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLE NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD2B409 MBSF530

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE