BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

    MDR report key: 4379926 · Received December 30, 2014

    Report

    Report Number
    3008845715-2014-00085
    Event Type
    Other
    Date Received
    December 30, 2014
    Date of Event
    December 9, 2014
    Report Date
    December 26, 2014
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    GAM
    PMA / PMN Number
    K072028
    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 HAS NOT BEEN RECEIVED. METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED HAS NOT BEEN RECEIVED. RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED HAS NOT BEEN RECEIVED. NO PRODUCT EVALUATION CAN BE PERFORMED AT THIS MOMENT. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT AS WELL AS THE SUTURE COMPONENT WERE 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. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. AT THE TIME OF THIS REPORT SAMPLES HAVE NOT BEEN RECEIVED. UPON RECEIPT OF SAMPLES A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVALUATION IS COMPLETED. 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 INFORMATION PROVIDED. (B)(4). ITEM #SXMD2B410 STRATAFIX SPIRAL PGA-PCL KNOTLESS TISSUE CONTROL DEVICE 2FS-1 2-0 UND MONODERM 30X30, LOT: MBZK690.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, "THERE WERE WOUND DEHISCENCE AFTER SUTURING WITH STRATAFIX DEVICES. TWO EVENTS OCCURRED IN SUBCUTICULAR SKIN LAYER" REF. PR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858412 STRATAFIX KNOTLESS TISSUE CONTROL DEVICE BARBED MATERIAL/NEEDLE GAM SURGICAL SPECIALTIES PUERTO RICO INC. SXMD2B410 MBZK690

    Patients

    Seq Age Sex Outcome Treatment
    1 NA NONE MADE AVAILABLE