BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1241602 · Received November 20, 2008

    Report

    Report Number
    2210968-2008-01144
    Event Type
    Injury
    Date Received
    November 20, 2008
    Report Date
    October 20, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 11/19/08. INFECTION OCCURRED, CONCLUSION CODE: A REVIEW OF THE BATCH MFG RECORDS WAS CONDUCTED. THIS REVIEW DID NOT IDENTIFY ANY NON-CONFORMANCES AND THE BATCH MET ALL STERILIZATION 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

    CUSTOMER REPORTED THAT A PT DEVELOPED A SURGICAL SITE INFECTION AT AN UNSPECIFIED TIME FOLLOWING A DERMATOLOGICAL PROCEDURE. IT IS ASSUMED THAT ANTIBIOTICS WERE PRESCRIBED TO ADDRESS THE EVENT. ADDITIONAL INFO WAS REQUESTED; NO FURTHER INFO WAS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AC2411

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention