BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 3870040 · Received June 12, 2014

    Report

    Report Number
    2210968-2014-07504
    Event Type
    Injury
    Date Received
    June 12, 2014
    Report Date
    May 22, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED STAPHYLOCOCCUS AUREUS INFECTION FOLLOWING WOUND CLOSURE WHEN THE PHYSICIAN REMOVED THE ORTHOPEDIC PINS EQUIPMENT. THE PATIENT RECEIVED ANTIBIOTIC THERAPY FOLLOWING NEW WOUND CLOSURE. THE SURGEON OPINES THAT THE INFECTION DID NOT COME FROM THE SUTURE BUT FROM THE MEPILEX BAND-AID DRESSING AND SOLUTION NOT BEING APPLIED AS IT SHOULD WITH CREATION OF AIR BUBBLES THAT COULD CAUSE INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348565 VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention MEPILEX