BEUDAMED
    FDA Adverse Event Other Summary report: N

    TISSUE FCPS 1X2 8

    MDR report key: 748879 · Received August 7, 2006

    Report

    Report Number
    1226348-2006-00220
    Event Type
    Other
    Date Received
    August 7, 2006
    Date of Event
    April 10, 2006
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    GEN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED THE DEVICE FOR EVAL. IT IS UNLIKELY THAT THE DEVICE WILL BE SENT IN FOR CODMAN TO EVALUATE. A LOT NUMBER HAS BEEN PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WILL BE PERFORMED. WE ANTICIPATE THAT THE DEVICE HISTORY RECORDS WILL REVEAL THAT THE PRODUCT CONFORMED TO ALL TESTING AND MFG SPECIFICATIONS PRIOR TO BEING RELEASED TO STOCK. IF ANYTHING OTHERWISE IS FOUND, A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND OR SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT AFTER USE, SCRUB TECH NOTICED THAT A "TOOTH" FROM THE "PICK UP FORCEP" WAS MISSING. THE FORCEP WAS USED ONLY TO ENTER ABDOMINAL FASCIA. THE INSTRUMENT WAS NOT USED IN THE ABDOMINAL CAVITY. AN X-RAY PERFORMED AFTER THE PROCEDURE WAS NORMAL. THERE WAS NO ADVERSE OUTCOME REPORTED. IT IS DOUBTFUL THAT THE PRODUCT WILL BE RETURNED FOR EVAL, (A MESSAGE WAS LEFT FOR THE CUSTOMER. NO RESPONSE AS OF YET). A LOT NUMBER HAS BEEN PROVIDED, THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORDS WILL NEED TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TISSUE FCPS 1X2 8 FORCEPS, GENERAL AND PLASTIC SURGERY GEN CODMAN & SHURTLEFF, INC. NA 89

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention