BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    MDR report key: 1940253 · Received December 9, 2010

    Report

    Report Number
    2210968-2010-01660
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 8, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, 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 EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. IN ADDITION, A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC HERNIA REPAIR PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING CLOSURE OF A 12 MM TROCAR SITE, THE NEEDLE BROKE 1/3 AWAY FROM THE SWAGE. THE SITE WAS HELD OPEN WITH RETRACTORS WHILE SUTURING. THE NEEDLE FRAGMENT WAS VISUALIZED AND REMOVED WITH THE USE OF A MAGNET. ANOTHER SUTURE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CGZ590

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK