BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WOUND PROTECTOR EXTRA SMALL

    MDR report key: 5046245 · Received September 1, 2015

    Report

    Report Number
    1219930-2015-00781
    Event Type
    Malfunction
    Date Received
    September 1, 2015
    Date of Event
    July 31, 2015
    Report Date
    December 9, 2015
    Manufacturer
    COVIDIEN, FORMERLY US SURGICAL A DIVISON
    Product Code
    KKX
    PMA / PMN Number
    K140064
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE OPENED BY THE ACCOUNT. THIS EVALUATION WAS BASED ON A TECHNICAL REVIEW OF ALL DATA RECEIVED FROM THE SITE, A PMV REVIEW OF MANUFACTURING RECORDS, A PMV REVIEW OF COMPLAINT TRENDS, AN ENGINEERING REVIEW OF THE PRODUCT AND AN EVALUATION OF THE RETURNED DEVICE. ENGINEERING DETERMINED THAT THE WELD WAS INCOMPLETE. A REVIEW OF THE DEVICE HISTORY RECORD INDICATES THIS DEVICE LOT NUMBER WAS RELEASED MEETING ALL QUALITY RELEASE SPECIFICATIONS AT THE TIME OF MANUFACTURE. REPLICATION OF THE REPORTED CONDITION WAS DUE TO AN INCOMPLETE WELD. SUBSEQUENTLY, THE COMPLAINT DATA DID NOT DISPLAY AN INCREASED TREND. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED AS A RESULT OF THE ALLEGED EVENT. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND REASSESSED AT THAT TIME.

    Additional Manufacturer Narrative · 1

    PHOTOGRAPH OF THE DEVICE RECEIVED ON 04 SEP 2016.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER. DURING A THORACO/LOBECTOMY, WHEN REMOVING FROM THE PACKAGE, PARTS AROUND BLUE RING WAS BEING BROKEN. OPENED ANOTHER. NO FURTHER INCIDENT. THE PRODUCT WAS NOT USED ON A PATIENT. OPERATING TIME NOT EXTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579518 WOUND PROTECTOR EXTRA SMALL DRAPE, SURGICAL KKX COVIDIEN, FORMERLY US SURGICAL A DIVISON WPXSM24 Z4L0010UX

    Patients

    Seq Age Sex Outcome Treatment
    1