BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACEMAKER PREPERITONEAL DIST BALLOON

    MDR report key: 6115892 · Received November 20, 2016

    Report

    Report Number
    2647580-2016-00979
    Event Type
    Malfunction
    Date Received
    November 20, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 25, 2016
    Manufacturer
    COVIDIEN, FORMERLY USSC PUERTO RICO INC
    Product Code
    GCJ
    PMA / PMN Number
    K935426
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Additional Manufacturer Narrative · 1

    (B)(4). POST MARKET VIGILANCE (PMV) LED AN EVALUATION OF ONE DEVICE. THE BALLOON WAS UNABLE TO BE INFLATED DUE TO THE OBSERVED CUT. PRODUCT ANALYSIS SUGGESTS THE PRODUCT WAS USED IN A SURGICAL PROCEDURE. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. NO ENHANCEMENTS OR IMPROVEMENTS WERE GENERATED FOR THE REPORTED CONDITION. REPLICATION OF THE REPORTED CONDITION MAY OCCUR AS A RESULT OF EITHER AN INFLATED OR DEFLATED BALLOON MAKING CONTACT WITH A SHARP OBJECT DURING USE. SHOULD NEW INFORMATION BECOME AVAILABLE, THE FILE WILL BE RE-OPENED AND THE INVESTIGATION SUMMARY WILL BE AMENDED AS APPROPRIATE.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER DURING A TEP HERNIA REPAIR THE BALLOON COULDN'T BE INFLATED. THE DEVICE WAS REPLACED TO CORRECT THE CONDITION. THE LAST KNOWN STATUS OF THE PATIENT IS REPORTED AS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766697 SPACEMAKER PREPERITONEAL DIST BALLOON LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ COVIDIEN, FORMERLY USSC PUERTO RICO INC OMSPDB1000 P6A0399X

    Patients

    Seq Age Sex Outcome Treatment
    1