BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1252800 · Received December 4, 2008

    Report

    Report Number
    2210968-2008-01230
    Event Type
    Injury
    Date Received
    December 4, 2008
    Date of Event
    November 4, 2008
    Report Date
    November 5, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 12/04/2008. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. 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.

    Description of Event or Problem · 1

    INTL CUSTOMER REPORTED THAT THE SEVEN OR EIGHT INTERRUPTED SUTURE KNOTS BROKE SIX DAYS FOLLOWING AN UNSPECIFIED SURGICAL PROCEDURE. THE PT WAS RETURNED TO SURGERY FOR REPAIR. NO FURTHER INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA AC6877

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention SUTURE - PDS II