BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATAFIX SPIRAL

    MDR report key: 7288394 · Received February 22, 2018

    Report

    Report Number
    7288394
    Event Type
    Malfunction
    Date Received
    February 22, 2018
    Date of Event
    January 31, 2018
    Report Date
    February 13, 2018
    Manufacturer
    SURGICAL SPECIALTIES
    Product Code
    NEW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BARBS ON SUTURE ARE SMALLER THAN BEFORE BUT OPENING OTHER PACKAGES OF SAME SUTURE BARBS ARE OF INCONSISTENT LENGTHS. BASICALLY - INCONSISTENT SUTURE QUALITY OF THREE DIFFERENT LOT NUMBERS EVALUATED (OTHER LOTS ARE MDDS230 AND AAB5721).

    Description of Event or Problem · 1

    BARBS ON SUTURE ARE SMALLER THAN BEFORE BUT OPENING OTHER PACKAGES OF SAME SUTURE BARBS ARE OF INCONSISTENT LENGTHS. BASICALLY - INCONSISTENT SUTURE QUALITY OF THREE DIFFERENT LOT NUMBERS EVALUATED (OTHER LOTS ARE MDDS230 AND AAB5721)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134359 STRATAFIX SPIRAL SUTURE, SURGICAL, ABSORBABLE, POLYDIOXANONE NEW SURGICAL SPECIALTIES SXPD2B405 AABP642

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown