BEUDAMED
    FDA Adverse Event Summary report: N

    SCHROEDER TENACULUM FCPS 10

    MDR report key: 1378567 · Received May 5, 2009

    Report

    Report Number
    2430952-2009-00005
    Date Received
    May 5, 2009
    Report Date
    May 5, 2009
    Product Code
    HDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. INTEGRA LIFESCIENCES CORPORATION IS FILLING ON BEHALF OF THE INITIAL DISTRIBUTOR J. JAMNER SURGICAL INSTRUMENTS. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORPORATION, (B)(4). ATTENTION: CORPORATE COMPLAINTS COORDINATOR.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE ORIGINAL PRODUCT WAS A PILLING # (B)(4). WHEN CROSS-REFERENCED TO USE YOUR PRODUCT, WE ORDERED A (B)(4). SINCE THEN, THE GYN CLINIC HAS HAD PATIENTS RETURNING DUE TO BLEEDING FOR CAUTERIZATION OF THE PUNCTURE SITES. THE DR LOOKED CLOSELY AND FOUND THAT THIS REPLACEMENT IS NOT THE SAME AS THE PILLING PRODUCT. IT IS MORE ROUNDED AT THE TIP. NOT A CORRECT CROSS-REFERENCE. THIS DEVICE HAS BEEN IN USE BY THE CUSTOMER SINCE (B)(4) 2008 THROUGH (B)(4), 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SCHROEDER TENACULUM FCPS 10 NA HDC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention