BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2240694 · Received September 9, 2011

    Report

    Report Number
    2210968-2011-01247
    Event Type
    Injury
    Date Received
    September 9, 2011
    Report Date
    August 19, 2011
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFECTION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. THIS IS ONE OF FIVE MEDWATCHES BEING SUBMITTED AS FIVE DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-01246, MEDWATCH 2210968-2011-01248, MEDWATCH 2210968-2011-01249, AND MEDWATCH 2210968-2011-01250. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A BILATERAL BREAST AUGMENTATION PROCEDURE ON (B)(6) 2011 AND SUTURE WAS USED. THE SUTURE WAS USED TO CLOSE THE POCKET FOR THE IMPLANT. APPROXIMATELY THREE WEEKS LATER, THE PATIENT CAME BACK TO OFFICE FOR FOLLOW UP EXHIBITING WHAT APPEARED TO BE STITCH ABSCESS. THE PATIENT WAS TREATED WITH ANTIBIOTICS, CIPRO AND FLAGYL, BUT DID NOT RESPOND AND INCISIONS OPENED UP. THE PATIENT UNDERWENT REOPERATION FOR EXPLANTATION OF THE BREAST IMPLANTS ON AN UNKNOWN DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention