BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1791326 · Received August 2, 2010

    Report

    Report Number
    2210968-2010-00871
    Event Type
    Malfunction
    Date Received
    August 2, 2010
    Date of Event
    July 5, 2010
    Report Date
    July 6, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A BOWEL REPAIR PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE FIRST PASS WITH THE NEEDLE WAS FINE, BUT IT WAS EXTREMELY DIFFICULT TO GET THE NEEDLE THROUGH THE TISSUE ON THE SECOND PASS. THE SURGEON BACKED THE NEEDLE OUT AND IT APPEARED AS IF THE TIP OF THE NEEDLE HAD BROKEN OFF. ANOTHER LIKE PRODUCT WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PT CONSEQUENCES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK