BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5MMX100MM DISPOSABLE NON THRD SEPARATOR

    MDR report key: 559894 · Received December 16, 2004

    Report

    Report Number
    2027111-2004-00018
    Event Type
    Injury
    Date Received
    December 16, 2004
    Date of Event
    November 23, 2004
    Report Date
    December 15, 2004
    Manufacturer
    APPLIED MEDICAL RESOURCES CORP.
    Product Code
    HET
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT BILATERAL TUBAL LIGATION PROCEDURE UTILIZING BLADELESS TROCAR AS DESCRIBED IN SECTION D OF THIS REPORT. PT DEVELOPED ABDOMINAL WALL HEMATOMA AT TROCAR INSERTION SITE, WHICH APPEARED TO BE STABLE AT TIME OF CLOSURE. PT SUBSEQUENTLY BEGAN HEMORRHAGING, NECESSITATING TRANSFER TO SICU. PT HAS RECOVERED FROM INCIDENT. FACILITY SWITCHED TO THIS BRAND/MODEL OF TROCAR THREE MONTHS AGO. A SIMILAR INCIDENT OCCURRED A COUPLE WEEKS AGO BUT INJURY WAS MINOR, IDENTIFIED/REPAIR DURING INITIAL PROCEDURE AND DID NOT RESULT IN PT MORBIDITY SEVERAL PHYSICIANS HAVE VERBALIZED CONCERN WITH THIS PARTICULAR SIZED MODEL THAT THE BLUNT DESIGN OF TIP REQUIRES CONSIDERABLE FORCE TO INSERT, WHILE INCREASE CHANCE OF PT INJURY. INJURY LOCATION STRONGLY SUGGEST SOURCE WAS TROCAR INSERTION. HAVE NOT PREVIOUSLY EXPERIENCED THESE COMPLICATIONS PRIOR TO CHANGE IN TROCAR MODEL. UNTIL ETIOLOGY OF PROBLEMS OF PROBLEMS, PRODUCT DESIGN VS USER ERROR, IS DETERMINE, FACILITY WILL NO LONGER USE THIS PARTICULAR SIZE MODEL IN MAIN PORT. MFR IS AWARE, WILL INVESTIGATE PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5MMX100MM DISPOSABLE NON THRD SEPARATOR * HET APPLIED MEDICAL RESOURCES CORP. C0957 130643

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Life Threatening| O