BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    MDR report key: 2894205 · Received January 3, 2013

    Report

    Report Number
    2210968-2013-00082
    Event Type
    Injury
    Date Received
    January 3, 2013
    Report Date
    December 11, 2012
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED ON (B)(6) 2012. THE PATIENT FIRST RETURNED WITH PERINEAL PAIN ON (B)(6) 2012. THE SECOND PROCEDURE WAS PERFORMED ON (B)(6) 2012 DUE TO ONGOING PAIN ASSOCIATED WITH INTERCOURSE. THE PATIENT UNDERWENT THE THIRD PROCEDURE ON (B)(6) 2012 DUE TO ONGOING PAIN. AT THAT TIME, THE SUTURE APPEARED NORMAL WITHOUT ANY EVIDENCE OF RESORPTION. THE PATIENT CONTINUES TO HAVE SOME PAIN, ALTHOUGH IT HAS LESSENED SINCE THE LAST REFASHIONING IN (B)(6) 2012. (B)(4).

    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 Manufacturer Narrative · 1

    (B)(4): THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THE RETURNED OPENED SAMPLE COMPRISED 3 PORTIONS OF MONOFILAMENT SUTURE MATERIAL THAT HAD BEEN PART OF KNOTS WITHIN THE PATIENT. THE SAMPLES WERE IDENTIFIED BY IR SPECTROSCOPY. THE RETURNED SAMPLE WAS NOT MONOCRY POLIGLECAPRONE 25 SUTURE. IT APPEARED THAT THE SAMPLE WAS A MONOFILAMENT NYLON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A VAGINAL WALL LACERATION REPAIR PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT EXPERIENCED DELAYED ABSORPTION OF THE SUTURE RESULTING IN A REOPERATION OF THE VAGINAL WALL REQUIRING THREE SEPARATE PROCEDURES BEING PERFORMED. THE SURGEON FOUND THAT THE SUTURE HAD NOT BEEN FULLY ABSORBED. THE PATIENT WAS EXPERIENCING EXCRUCIATING PAIN POST SURGERY AND HAD SOME OF THE STITCHES REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2924 MONOCRYL (POLIGLECAPRONE 25) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention