BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 3003761 · Received March 14, 2013

    Report

    Report Number
    2210968-2013-02409
    Event Type
    Injury
    Date Received
    March 14, 2013
    Report Date
    February 28, 2013
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. ADDITIONAL INFORMATION: THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: BATCH EGS157, MFG DATE: 06/01/2012, EXP DATE: 06/30/2017. BATCH EMS770, MFG DATE: 11/01/2012, EXP DATE: 11/30/2017. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND THE BATCHES MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR PACKAGING INTEGRITY AND WERE FOUND TO MEET REQUIREMENTS. NO DEVIATIONS WERE OBSERVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A JOINT REPLACEMENT SURGERY ON (B)(6) 2013 AND SUTURE WAS USED. APPROXIMATELY THREE WEEK POST OPERATIVE, THE PATIENT EXPERIENCED INFLAMMATION AND WOUND DEHISCENCE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107520 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE. GAM ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention