BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL SUTURE

    MDR report key: 1823334 · Received August 30, 2010

    Report

    Report Number
    2210968-2010-01000
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 24, 2010
    Report Date
    July 28, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PT UNDERWENT AN UNK PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. THE NEEDLE BROKE DURING THE SURGERY. THE BROKEN PART DID NOT FALL INTO THE PT. THERE WERE NO ADVERSE PT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA T9001

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK