BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE

    MDR report key: 2052250 · Received April 12, 2011

    Report

    Report Number
    2210968-2011-00414
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    March 12, 2011
    Report Date
    March 15, 2011
    Manufacturer
    ETHICON. SAS AUNEAU
    Product Code
    GAM
    PMA / PMN Number
    K033746
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: 04/12/2011. (B)(4) - PRE-ABSORPTION OCCURRED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. 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

    DATE SENT TO THE FDA: 05/02/2011. RESULT: A REPRESENTATIVE SAMPLE OF THE PRODUCT WAS RETURNED FOR EVALUATION. THE PRODUCT WAS INSPECTED AND TESTED FOR KNOT PULL TENSILE STRENGTH . THERE WERE NO SIGNS OF MANUFACTURING OR MATERIAL DEFECTS FOUND. CONCLUSION: NO DEVICE FAILURE DETECTED AND THE PRODUCT IS WITHIN SPECIFICATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A MEDIOLATERAL EPISIOTOMY ON (B)(6) 2011 AND SUTURE WAS USED. SEVEN DAYS AFTER THE PROCEDURE, THE PATIENT'S WOUND WAS OPEN. THE SUTURE COULD BE SEEN AND PART OF THE SUTURE WAS ABSORBED. THE SURGEON REMOVED THE SUTURE AND USED A SILK SUTURE TO CLOSE THE WOUND. CURRENTLY, THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL RAPIDE (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON. SAS AUNEAU NA CK2BHBM0

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention