BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 1212106 · Received October 24, 2008

    Report

    Report Number
    2210968-2008-01039
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 11, 2008
    Report Date
    September 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES, AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFO BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    INTERNATIONAL CUSTOMER REPORTED THAT A PT DEVELOPED A WOUND DEHISCENCE SIX DAYS FOLLOWING A C-SECTION. THE SURGEON REPORTS THAT THE SURGICAL SITE CANNOT HEAL. NO FURTHER INFO RECEIVED. ASSUMED INTERVENTION PERFORMED TO CORRECT THE SITUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VICRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AC2500

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Required Intervention