BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYSORB 2-0 UD 5X18 BTP-1 DT

    MDR report key: 1504494 · Received September 30, 2009

    Report

    Report Number
    1219930-2009-00648
    Event Type
    Injury
    Date Received
    September 30, 2009
    Date of Event
    August 27, 2009
    Report Date
    September 3, 2009
    Manufacturer
    NORTH HAVEN - USS
    Product Code
    GAM
    PMA / PMN Number
    K963253
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF INITIAL REPORT SENT: 09/29/2009.

    Description of Event or Problem · 1

    PROCEDURE TYPE: SKIN CLOSURE (ABDOMINAL) ACCORDING TO THE REPORTER: WHILE SUTURING FASCIAS, THE TIP OF THE NEEDLE (ABOUT 5MM IN LENGTH) BROKE. A NURSE NOTICED IT WHEN RECEIVING AFTER THE DOCTOR HAD FINISHED USING THE SUTURE. ALTHOUGH THE PT WAS X-RAYED, THE BROKEN TIP COULD NOT BE FOUND. THERE WAS NO BLEEDING, AND NO TISSUE DAMAGE. OPERATING TIME WAS EXTENDED LESS THAN 30 MINUTES. PT STATUS IS FINE. NO OTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYSORB 2-0 UD 5X18 BTP-1 DT ABSORBABLE SUTURE PRODUCT GAM NORTH HAVEN - USS A8M685

    Patients

    Seq Age Sex Outcome Treatment
    1 Other