BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CBC CONSTAVAC

    MDR report key: 12892 · Received February 9, 1994

    Report

    Report Number
    12892
    Event Type
    Injury
    Date Received
    February 9, 1994
    Date of Event
    January 18, 1994
    Report Date
    February 9, 1994
    Manufacturer
    STRYKER CORP.
    Product Code
    GCY
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT A LEFT TOTAL KNEE REPLACEMENT. A DRAIN WAS PLACED DURING SURGERY. IT WAS NOTED THAT THERE WAS A SCANT AMOUNT OF DRAINAGE IN THE DRAIN TUBING POST-OP. THE FOLLOWING DAY, IT WAS NOTED THAT THE PT WAS EXPERIENCING NO MOVEMENT IN THE LEFT FOOT. THE DRAIN WAS IMMEDIATELY REMOVED AND A LARGE AMOUNT OF DRAINAGE WAS EXPRESSED FROM THE SITE. THE PT CONTINUED TO HAVE NO MOVEMENT IN THE FOOT AND WAS DETERMINED TO HAVE PERONEAL MOTOR NERVE PALSY. THE PT WAS DISCHARGED REQUIRING THE USE OF A BRACE FOR THE FOOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC CONSTAVAC WOUND DRAIN GCY STRYKER CORP. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention| S