BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 1842392 · Received September 17, 2010

    Report

    Report Number
    2210968-2010-01119
    Event Type
    Malfunction
    Date Received
    September 17, 2010
    Date of Event
    July 8, 2010
    Report Date
    August 17, 2010
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSIONS: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON (B)(6) 2010 AND SUTURE WAS USED. DURING SUTURING POST CESAREAN SECTION, THE NEEDLE BROKE IN HALF. THE NEEDLE PIECES WERE REMOVED DURING THE SAME PROCEDURE. THIS WAS THE PATIENT'S THIRD CESAREAN SECTION AND THE PATIENT HAD SIGNIFICANT SCAR TISSUE THAT WAS THICK AND TOUGH TO SUTURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA CE2060

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK