BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROXIMATE PPH PROCEDURE SET

    MDR report key: 2830669 · Received November 13, 2012

    Report

    Report Number
    3005075853-2012-05146
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K051301
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): INFORMATION UNAVAILABLE. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT FOLLOWING A PPH PROCEDURE, THE PATIENT RETURNED FOR POST-OP BLEEDING. DURING THE PROCEDURE, EVERYTHING WENT WELL; THERE WERE NO ISSUES WITH THE DEVICE. IT WAS USED ACCORDING TO INSTRUCTION FOR USE AND IT PERFORMED AS INTENDED. THERE WERE NO OTHER REPORTED PATIENT CONSEQUENCES. ADDITIONAL INFORMATION HAS BEEN REQUESTED, NO RESPONSE HAS BEEN RECEIVED TO DATE, A SUPPLEMENTAL REPORT WILL BE SENT UPON RECEIPT OF ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE PPH PROCEDURE SET STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. UNK ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention