BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLIP SLINGS

    MDR report key: 2417751 · Received January 3, 2012

    Report

    Report Number
    3004468271-2012-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2012
    Date of Event
    November 26, 2011
    Report Date
    December 5, 2011
    Manufacturer
    MEDIBO MEDICAL PRODUCTS N.V.
    Product Code
    FNG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH ON BEHALF OF THE MFR MEDIBO MEDICAL PRODUCTS NV. THE EVAL OF THE DEVICE TO DATE HAS BEEN CARRIED OUT BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR'S INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT THE SLING CLIP SNAPPED DURING USE, HOWEVER, NO INJURIES WERE INCURRED BY THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLIP SLINGS SLING FNG MEDIBO MEDICAL PRODUCTS N.V. MAA4031-L

    Patients

    Seq Age Sex Outcome Treatment
    1 Other