BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VERSAPOINT

    MDR report key: 1810028 · Received August 12, 2010

    Report

    Report Number
    2210968-2010-00927
    Event Type
    Injury
    Date Received
    August 12, 2010
    Date of Event
    April 9, 2010
    Report Date
    July 12, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    HIH
    PMA / PMN Number
    K040302
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - ILEOSTOMY. CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A SURGICAL OPERATION TO REMOVE AN INTRA-UTERINE POLYP ON (B)(6) 2010. TWO DAYS AFTER THE PROCEDURE, THE PT UNDERWENT AN URGENT RE-OPERATION IN A DIFFERENT HOSP AND AN INTESTINAL LESION OF THE SIGMOID COLON WAS DIAGNOSED. THE INTESTINAL DAMAGE WAS SUTURED AND A TEMPORARY ILEOSTOMY WAS CONSTRUCTED. ON AN UNK DATE, THE PT UNDERWENT A PROCEDURE TO CLOSE THE ILEOSTOMY. THERE WAS NO IMPACT ON THE PT'S REPRODUCTIVE CAPACITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERSAPOINT ELECTRODE HIH ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention