BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENROSE DRAIN 12 X 3 4

    MDR report key: 2054110 · Received April 13, 2011

    Report

    Report Number
    1423537-2011-00019
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 21, 2011
    Report Date
    April 13, 2011
    Manufacturer
    CARDINAL HEALTH
    Product Code
    LRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER OF PENROSE DRAIN, KENT ELASTOMER PRODUCTS INC., HAS DECLINED TO FILE AN MDR FOR THIS ISSUE. THEY NOTIFIED CARDINAL HEALTH OF THIS DECISION ON (B)(4) 2011. CARDINAL HEALTH IS REPORTING AS THE KIT COMPILER. REVIEW FROM KENT ELASTOMER PRODUCTS INC. STATES: NOT ABLE TO SEE OR EVALUATE THE SAMPLE (WHICH WAS PACKAGED AND LABELED AS "BIOHAZARD"). REVIEW OF THE DEVICE HISTORY RECORDS (RAW MATERIAL TO FINISHED PRODUCT) FROM THE REPORTED LOT NUMBER REVEALED, THE PROCESS AND INSPECTION CRITERIA WERE COMPLIANT WITH FINISHED PRODUCT SPECIFICATIONS. NOT ABLE TO DETERMINE ROOT CAUSE.

    Description of Event or Problem · 1

    WHEN REMOVING PENROSE, DRAINS BROKE AND PATIENT HAD TO UNDERGO SURGERY TO REMOVE THEM.  PATIENT WAS RELEASED FOLLOWING THE REMOVAL AND NO UNTOWARD AFFECTS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENROSE DRAIN 12 X 3 4 PENROSE DRAIN 12 X 3 4 LRO CARDINAL HEALTH 30414-075 597025

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention