BEUDAMED
    FDA Adverse Event Other Summary report: N

    SCHROEDER TENACULUM FCPS 10

    MDR report key: 1423224 · Received July 4, 2009

    Report

    Report Number
    8043404-2009-00001
    Event Type
    Other
    Date Received
    July 4, 2009
    Report Date
    May 5, 2009
    Product Code
    HTD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INSTRUMENT IN QUESTION WAS MFG IN (B)(4) 2008 AND DELIVERED TO THE DISTRIBUTOR WITH OUR INVOICE NO 1116C DATED (B)(4), 2009. WE ARE ABLE TO TRACE BACK OUR DELIVERIES OF THIS ITEM TO THE DISTRIBUTOR TO (B)(4) 2003. SINCE THEN A TOTAL OF 4086 PCS. HAVE BEEN DELIVERED WITHOUT BEING MADE AWARE OF ANY OTHER INCIDENT OF THIS NATURE. A HARDNESS TEST ON THE RETURNED DEVICE PRODUCED A VALUE OF 48,0 HRC, WHICH IS WELL WITHIN THE TOLERANCE RANGE OF 44-48 HRC PRESCRIBED BY STANDARD ISO (B)(4). VISUAL INSPECTION REVEALED NO DEVIATION. THE DEVICE MEETS ALL SPECIFICATIONS WHEN COMPARED TO THE DESIGN DRAWING AND THE MASTER SAMPLE. WE HAVE NO EXPLANATION FOR HOW THIS INSTRUMENT MIGHT HAVE CAUSED THE BLEEDING OTHER THAN IMPROPER USE AND HANDLING OF THE DEVICE. ADDITIONAL INFO FROM IMPORTER REPORT #2430952-2009-00005: (B)(4). THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO. INTEGRA LIFESCIENCES CORP IS FILING ON BEHALF OF THE INITIAL DISTRIBUTOR J JAMNER SURGICAL INSTRUMENTS. CORRESPONDENCE SHOULD BE SENT TO: INTEGRA LIFESCIENCES CORP; (B)(4).

    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 JARIT (B)(4). SINCE THEN, THE GYN CLINIC HAS HAD PTS RETURNING DUE TO BLEEDING FOR CAUTERIZATION OF THE PUNCTURE SITES. THE DR'S 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)(6) 2008 THROUGH (B)(6), 2009.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention