BEUDAMED
    FDA Adverse Event Other Summary report: N

    STRATAFIX KNOTLESS TISSUE CONROL DEVICE

    MDR report key: 4834223 · Received June 8, 2015

    Report

    Report Number
    3008845715-2015-00054
    Event Type
    Other
    Date Received
    June 8, 2015
    Report Date
    June 4, 2015
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO INC.
    Product Code
    NEW
    PMA / PMN Number
    05/20/2015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. METHOD: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. 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 SPECIALITIES (B)(4), INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING, AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. DEHISCENCE, IS A KNOWN RISK WITH ANY SUTURE MATERIAL. THE MOST PROBABLE ROOT CAUSE FOR POST OPERATIVE DEHISCENCE AND INFECTION CANNOT BE DETERMINED WITH CERTAINTY BASAD ON THE INFORMATION PROVIDED, WITHOUT REVIEWING THE ACTUAL DEVICE INVOLVED OR REVIEWING OR TESTING, STERILE SAMPLES FROM THE SAME FINISHED GOODS LOT. REFERENCE: COMPLAINT (B)(4); (ETHICON COMPLAINT(B)(4)), ITEM: (B)(4) STRATAFIX SPIRAL PDO KNOTLESS TISSUE CONTROL DEVICE - (B)(4) PDO 45CM, LOT MCJH230.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE REP, THAT IN 8 DIFFERENT CASES OF WOUND DEHISCENCE WERE EXPERIENCED AND WOUND INFECTION WERE EXPERIENCED 2-3 WEEKS POST-OP WHERE STRATAFIX DEVICES WERE USED TO CLOSE SUBCUTANEOUS TISSUE LAYER. REP RECEIVED ADDITIONAL INFORMATION ON (B)(6) 2015 - ONE PATIENT EXPERIENCED: INFECTION, WOUND DEHISCENCE AND IMPLANT EXPOSURE, PATIENT WAS REVISED AND BREAST IMPLANT WAS REMOVED ON AN UNSPECIFIED DATE. PR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369416 STRATAFIX KNOTLESS TISSUE CONROL DEVICE BARBED MATERIAL/NEEDLES NEW SURGICAL SPECIALTIES PUERTO RICO INC. SXPD1B100 MCJH230

    Patients

    Seq Age Sex Outcome Treatment
    1 NA