BEUDAMED
    FDA Adverse Event Injury Summary report: N

    P-FLEX SET POOLE X-RAY/350

    MDR report key: 3213835 · Received July 3, 2013

    Report

    Report Number
    3007966929-2013-00001
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    CONVATEC
    Product Code
    KDC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORT FILED ON (B)(4) 2013, (3005778470-2013-00025). INCORRECT MFG SITE LISTED. THIS REPORT HAS CORRECT SITE AND REPORT NUMBER. GREEN PLASTIC PART CAME OFF SUCTION AND ENDED UP IN PT'S UMBILICUS. REMAINING STOCK X 5 REMOVED. WE HAVE THE BROKEN PART BUT NOT THE TUBING. BASED ON THE AVAILABLE INFO, THE AE IS DEEMED A SERIOUS INJURY AS IT REQUIRED A SURGICAL INTERVENTION TO RETRIEVE THE BROKEN OFF PIECE OF THE SUCTION DEVICE. NO OTHER DETAILS ARE KNOWN TO US AS AT NOW. FROM A CLINICAL PERSPECTIVE, A CAUSAL RELATIONSHIP BETWEEN THE OP-FLEX SET POOLE AND THIS EVENT IS DEEMED POSSIBLE BECAUSE PRODUCT IS TEMPORALLY ASSOCIATED WITH THE PART OF THE BODY WHERE THE PROBLEM OCCURRED. EFFORTS TO OBTAIN FURTHER INFO ON THE CIRCUMSTANCES OF THIS EVENT AND THE PT'S DETAILS HAVE NOT PROVED SUCCESSFUL SO FAR. IT'S UNCLEAR, BASED ON THE INFO PROVIDED SO FAR THE PLACE OF DISCONNECTION. ONE UNUSED SAMPLE WAS RECEIVED WITH THE REFERENCE TO THIS COMPLAINT. COMPLAINANT ORDER (B)(4) WAS PRODUCED. DHR WAS REVIEWED AND THERE WERE NO DEVIATIONS INITIATED FOR THESE ORDER. SAMPLE WAS TESTED. THE RESULTS ARE OK. ADD'L INFO FROM THE CUSTOMER IS BEING REQUESTED TO INVESTIGATE THE ISSUE FURTHER. RECEIVED MESSAGE FROM CUSTOMER THAT NO ADD'L INFO WILL BE PROVIDED FOR THIS EVENT. NOTE: THE ACTUAL DATE OF EVENT IS UNK, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE. REPORTED TO FDA ON (B)(4) 2013.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED AS FOLLOWS: "PRODUCT WAS BEING USED IN THEATRE, GREEN PART DISCONNECTED AND LODGED IN PT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    304008 P-FLEX SET POOLE X-RAY/350 INSTRUMENT, SURGICAL, DISPOSABLE KDC CONVATEC 34071182 641309

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention