BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL PLUS (POLYGLACTIN 910) SUTURE

    MDR report key: 1940252 · Received December 9, 2010

    Report

    Report Number
    2210968-2010-01661
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 1, 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. ADDITIONAL INFO: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. A POSSIBLE BATCH NUMBER IS REPORTED AS FOLLOWS: BATCH CGZ590, MFG DATE: 06/01/2010, EXP DATE: 01/31/2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE IN EARLY (B)(6) 2010, AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE. THE NEEDLE FRAGMENT WAS REMOVED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK