BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 261944 · Received February 11, 2000

    Report

    Report Number
    2210968-2000-00027
    Event Type
    Injury
    Date Received
    February 11, 2000
    Date of Event
    February 1, 1995
    Report Date
    January 20, 2000
    Manufacturer
    ETHICON, INC. SAN ANGELO
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE ATTORNEY THAT THE PLAINTIFF HAD AN OPEN HEART BYPASS SURGERY IN 1995 AT A MEDICAL CENTER. THE SURGEON CLOSED THE MEDIASTINUM WITH SIZE 1 VICRYL AND 2-0 VICRYL AND SKIN CLIPS ON THE SKIN. ON 02/01/1995, IT WAS DOCUMENTED THAT THE PT "HAD A STERNAL INFECTION, CULTURE STAPHLOCCOCCUS AURES AND EC FAECALLS AND STAPHAEMOLYTICUS." ATTORNEY ALLEGES THAT THE USE OF VICRYL SUTURES LED TO A STERNAL INFECTION WHICH REQUIRED THE REMOVAL OF THE STERNAL BONE AND MULTIPLE SURGERIES TO THE PLAINTIFF.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention