BEUDAMED
    FDA Adverse Event Other Summary report: N

    LAPAROSCOPIC DRAPE BLUE 15

    MDR report key: 1371648 · Received February 13, 2009

    Report

    Report Number
    2083545-2009-00002
    Event Type
    Other
    Date Received
    February 13, 2009
    Date of Event
    January 14, 2009
    Report Date
    February 12, 2009
    Manufacturer
    A PLUS INTERNATIONAL
    Product Code
    KKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INCIDENT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. TO DATE, A ROOT CAUSE HAS NOT BEEN IDENTIFIED. INVESTIGATION PROCESS IS ON-GOING. A FOLLOW-UP REPORT WILL BE PROVIDED IF ADDITIONAL INFO BECOMES AVAILABLE. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEMS. ONGOING ANALYSIS OF TREND INFO IS USED TO IDENTIFY THE NEED FOR ADDITIONAL INVESTIGATIONS.

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED TO THE MANUFACTURER BY A KIMBERLY CLARK SALES REP THAT THE VELCRO TABS ARE ALLEGEDLY "FLYING OFF". THE VELCRO TABS REPORTEDLY LANDED IN THE SURGICAL WOUND AND WAS REMOVED. THERE WAS NO REPORT OF SERIOUS INJURY OR DEATH AS RESULT OF THE PRODUCT PROBLEM. KIMBERLY-CLARK HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFO THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE KIMBERLY-CLARK COMPLAINT DATABASE AND IDENTIFIED AS (B) (4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAPAROSCOPIC DRAPE BLUE 15 SURGICAL DRAPES KKX A PLUS INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1