BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATAFIX

    MDR report key: 8019314 · Received October 30, 2018

    Report

    Report Number
    3010692967-2018-00024
    Event Type
    Injury
    Date Received
    October 30, 2018
    Date of Event
    June 21, 2018
    Report Date
    October 30, 2018
    Manufacturer
    SURGICAL SPECIALTIES PUERTO RICO, INC.
    Product Code
    NEW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO SURGICAL SPECIALTIES CORPORATION FOR ROOT CAUSE ANALYSIS. THE PRODUCT CODE AND LOT NUMBER HAVE NOT BEEN PROVIDED WHICH PRECLUDES A DHR REVIEW FROM BEING PERFORMED AT THIS TIME. UNFORTUNATELY WITHOUT THE DEVICE OR LOT INFORMATION WE ARE UNABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. SHOULD THE DEVICE BE RETURNED TO SURGICAL SPECIALTIES CORPORATION AT SOME POINT IN THE FUTURE THE ISSUE WILL BE RE-OPENED, THE DEVICE EVALUATED AND THE FINDINGS FROM THE EVALUATION WILL BE DOCUMENTED IN THE COMPLAINT FILE. NO FURTHER CORRECTIVE OR PREVENTATIVE ACTION IS REQUIRED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE SALES REP THAT AFTER A RIGHT SUB COSTAL INCISION, COMMON BILE DUCT EXPLORATION PROCEDURE THAT THE SURGEON STATED THAT THEY FOUND THAT THE WOUND WAS INFECTED AND APPEARED THAT THE SUTURE BROKE AND THERE WAS WOUND DEHISCENCE. UNKNOWN AS TO HOW THE ISSUE WAS TREATED. PATIENT CURRENT STATUS IS UNKNOWN. DUE TO THE REPORT OF INFECTION AND WOUND DEHISCENCE, THIS CASE WAS DEEMED REPORTABLE TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858890 STRATAFIX UNK STRATAFIX SPIRAL PDO NEW SURGICAL SPECIALTIES PUERTO RICO, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other