BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BENEHOLD MEDICAL TAPE STRIPS

    MDR report key: 2556253 · Received April 26, 2012

    Report

    Report Number
    3005360738-2012-00003
    Event Type
    Injury
    Date Received
    April 26, 2012
    Date of Event
    March 28, 2012
    Report Date
    March 30, 2012
    Manufacturer
    AVERY DENNISON BELGIE, BVBA
    Product Code
    KGX
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS PART OF THE COMPLAINT INVESTIGATION, THE MANUFACTURING PROCESS, RETAINED PRODUCT SAMPLES, AND ANY PRODUCT RETRIEVED FROM THE CUSTOMER WERE EVALUATED. THE INVESTIGATION WAS CONCLUDED AND SHOWED THAT THE PRODUCT HAD MET SPECIFICATIONS. ACTIVITIES ARE SUMMARIZED.

    Description of Event or Problem · 1

    PRODUCT USED TO ANCHOR ARTERIAL NEEDLE DURING DIALYSIS THERAPY. ARTERIAL NEEDLE BECAME DISLODGED DUE TO TAPE NOT ADHERING SUFFICIENTLY. THE VASCULAR ACCESS WAS OBSERVED TO BE CLOTTED OFF. UNKNOWN IF THROMBOSIS WAS A RESULT OF NEEDLE DISLODGEMENT. PATIENT WAS SENT TO THE HOSPITAL, WHERE THE VASCULAR ACCESS WAS DE-CLOTTED AND DIALYSIS WAS PERFORMED. PATIENT RELEASED ON MARCH 30 AND IS DOING FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BENEHOLD MEDICAL TAPE STRIPS TAPE ON A SHEET KGX AVERY DENNISON BELGIE, BVBA 9533186

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| L| R FISTULA NEEDLE