BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3021646 · Received March 26, 2013

    Report

    Report Number
    2210968-2013-02755
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    August 9, 2012
    Report Date
    August 15, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE RETURNED SAMPLES COMPRISED OF 6 EMPTY FOIL PACKS PLUS AN EMPTY LABELLED WINDING FORMER. NO SUTURES WERE RETURNED FROM EITHER COMPLAINT. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE MEDWATCH 2210968-2013-02756. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A NEUROSURGICAL PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. WHILE DISPENSING THE PRODUCT, THE NEEDLE PULLED OFF THE SUTURE. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124405 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE ABSORBABLE GAM ETHICON, INC. NA EE5DJGN

    Patients

    Seq Age Sex Outcome Treatment
    1