BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SUTURE PRODUCT

    MDR report key: 3144649 · Received June 4, 2013

    Report

    Report Number
    2210968-2013-06483
    Event Type
    Injury
    Date Received
    June 4, 2013
    Report Date
    May 16, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. ADDITIONAL INFORMATION: THERE ARE TWO POSSIBLE DEVICES INVOLVED IN THE EVENT AS FOLLOWS: MONOCRYL (POLIGLECAPRONE 25) SUTURE, COATED VICRYL (POLYGLACTIN 910) SUTURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A SMASECTOMY TYPE FACE LIFT IN 2004 AND SUTURE WAS USED. THE PATIENT DEVELOPED AN UNUSUAL SUBCUTANEOUS TISSUE REACTION AMOUNTING TO INTRADERMAL ABSCESSES. THIS STARTED ABOUT TWO WEEKS POST SURGERY AND NO ORGANISMS WERE EVER GROWN. THREE MONTHS POST SURGERY, THE SURGEON RE-EXPLORED THE FACE AND WASHED IT OUT. THE SURGICAL FIELD AT EXPLORATION WAS PRISTINE BUT THERE WERE SOME TINY INTRADERMAL ABSCESSES. TWO MONTHS AGO THE SURGEON CARRIED OUT A REVISION FACE LIFT FOR THE PATIENT AND ONCE AGAIN THE PATIENT HAS DEVELOPED A SIGNIFICANT SUBCUTANEOUS TISSUE REACTION AMOUNTING TO INFLAMMATION AND COLLECTIONS OF STERILE PUS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245791 UNKNOWN SUTURE PRODUCT SUTURE GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention