BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIMAX DETACHABLE NYLON SPECIMEN BAG 3X6

    MDR report key: 6339565 · Received February 17, 2017

    Report

    Report Number
    3007216334-2017-00020
    Event Type
    Malfunction
    Date Received
    February 17, 2017
    Date of Event
    January 25, 2017
    Report Date
    February 17, 2017
    Manufacturer
    UNIMAX MEDICAL SYSTEMS, INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FINAL REPORT WILL BE FILED BY (B)(4) WITH THE EVALUATION RESULTS AND/OR INVESTIGATION FINDINGS.

    Description of Event or Problem · 1

    AS REPORTED, DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2017, THE UNIMAX DETACHABLE NYLON SPECIMEN BAG 3X6 BROKE AT THE BASE SEAM WHEN ATTEMPTING TO REMOVE THE SPECIMEN FROM THE PERITONEAL CAVITY. ANOTHER VENDOR'S BAG WAS USED TO RETRIEVE THE UNIMAX SPECIMEN BAG AND THE SPECIMEN. THERE WAS NO REPORTED PATIENT INJURY. THERE HAS BEEN NO OTHER INFORMATION PROVIDED ON THIS COMPLAINT OR THE PATIENT'S CURRENT STATUS. THIS REPORT IS BEING FILED AS A REPORTABLE MALFUNCTION WITH THE POTENTIAL FOR INJURY WITH RECURRENCE. THE LEGAL MANUFACTURER UNIMAX MEDICAL SYSTEMS, INC. HAS THE COMPLAINT INVESTIGATION RESPONSIBILITY AND NOTIFICATION HAS BEEN SENT TO THE MANUFACTURER ON 26-JANUARY-2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121367 UNIMAX DETACHABLE NYLON SPECIMEN BAG 3X6 LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS, INC. 8251608269

    Patients

    Seq Age Sex Outcome Treatment
    1 Other