BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

    MDR report key: 3781121 · Received April 30, 2014

    Report

    Report Number
    2210968-2014-05463
    Event Type
    Injury
    Date Received
    April 30, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 10, 2014
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K032420
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.THIS MEDWATCH REPORT IS IN RESPONSE TO RECEIPT OF VOLUNTARY MEDWATCH REPORT # (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC RIGHT HEMICOLECTOMY FOR THE TREATMENT OF COLON CANCER ON (B)(6) 2014 AND SUTURE WAS USED. THE PATIENT WAS DISCHARGED ON (B)(6) 2014. FOLLOWING THE PROCEDURE APPROXIMATELY ON (B)(6) 2014, THE PATIENT SNEEZED VERY HARD AND FELT A STINGING IN HIS INCISION. HE NOTED AN INCREASED SWELLING ON HIS STOMACH WHICH BECAME VERY UNCOMFORTABLE. AFTER EXAMINATION, IT WAS DETECTED A FASCIAL DEHISCENCE. THE PATIENT WAS BROUGHT BACK FOR SURGERY TO CLOSE THE ABDOMINAL WALL DUE TO DEHISCENCE OF ABDOMINAL INTRAUMBILICAL INCISION WITH PREMATURE RUPTURE OF SUTURE. THE KNOTS AND FASCIAL EDGES WERE INTACT. THE SUTURE APPEARED TO DISINTEGRATE/DISSOLVE IN ITS MID-PORTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A LAPAROSCOPIC RIGHT HEMICOLECTOMY ON (B)(6) 2014 AND SUTURE WAS USED. FOLLOWING THE PROCEDURE APPROXIMATELY ON (B)(6) 2014, THE PATIENT SNEEZED VERY HARD AND FELT A STINGING IN HIS INCISION. HE NOTED AN INCREASED SWELLING ON HIS STOMACH WHICH BECAME VERY UNCOMFORTABLE. AFTER EXAMINATION, IT WAS DETECTED A FASCIAL DEHISCENCE. THE PATIENT WAS BROUGHT BACK FOR SURGERY TO CLOSE THE ABDOMINAL WALL DUE TO DEHISCENCE OF ABDOMINAL INTRAUMBILICAL INCISION WITH PREMATURE RUPTURE OF SUTURE. THE KNOTS AND FASCIAL EDGES WERE INTACT. THE SUTURE APPEARED TO DISINTEGRATE/DISSOLVE IN ITS MID-PORTION. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    259585 VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention