BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2113305 · Received June 3, 2011

    Report

    Report Number
    2210968-2011-00718
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Report Date
    May 13, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Product Problem
    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. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: REPRESENTATIVE SAMPLES OF THE RETURNED PRODUCT WERE VISUALLY EXAMINED AND NO DEFECT WAS FOUND. THE STRENGTH DATA RECORDED WAS IN CONFORMANCE WITH THE REQUIREMENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN EPISIOTOMY REPAIR PROCEDURE AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE IN THE MUSCLE AND COULD NOT BE RETRIEVED FROM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE COATED VICRYL (POLYGLACTIN 910) SUTURE GAM ETHICON INC NA BM8HZQM0

    Patients

    Seq Age Sex Outcome Treatment
    1