BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2063297 · Received April 19, 2011

    Report

    Report Number
    2210968-2011-00461
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    March 23, 2011
    Manufacturer
    ETHICON,INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4). WOUND DEHISENCE. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CESAREAN SECTION PROCEDURE ON AN UNKNOWN DATE AND SUTURE WAS USED. THE PATIENT HAD NOTICED SOME BULGING UNDER THE SURFACE BUT INITIALLY PUT THIS DOWN TO SWELLING. THE FOLLOWING DAY AFTER THE SKIN SUTURES WERE REMOVED, THE PATIENT SNEEZED AND THE ABDOMEN BURST OPEN. THE SURGEON NOTICED THAT THE SUTURE HAD DISINTEGRATED IN THE CENTER. THE SUTURE USED AT THE TIME OF CLOSURE WAS A CONTINUOUS STITCH WITH A KNOT AT EITHER END. THE KNOTS WERE STILL INTACT AND IN PLACE. THE PATIENT WAS READMITTED AND UNDERWENT FURTHER SURGERY TO REPAIR THE BURST ABDOMEN AND TREATED THE PATIENT FOR SYMPTOMS OF BRADYCARDIA AND OTHER UNDEFINED POSTOPERATIVE COMPLICATIONS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention