BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 1973882 · Received January 20, 2011

    Report

    Report Number
    2210968-2011-00062
    Event Type
    Injury
    Date Received
    January 20, 2011
    Date of Event
    December 17, 2010
    Report Date
    December 20, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN ANTERIOR VAGINAL REPAIR PROCEDURE ON (B)(6) 2010. DURING THE PROCEDURE, THE NEEDLE BECAME DETACHED FROM THE SUTURE AT THE SWAGE AND WAS LOST IN THE PT. THE PT WAS X-RAYED AND THE NEEDLE WAS FOUND. IT WAS REQUIRED TO GO BACK AND FIND AND REMOVE THE NEEDLE FROM THE PT. THERE WERE NO SIDE EFFECTS AND THE WOUND WAS RE-CLOSED AS NORMAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CH2GCHM0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention