BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL

    MDR report key: 3231303 · Received July 17, 2013

    Report

    Report Number
    2210968-2013-13505
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    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 MAUDE EVENT REPORT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT HE UNDERWENT A ROTATOR CUFF REPAIR PROCEDURE ON (B)(6) 2013 AND SUTURE WAS USED. TWO WEEKS FOLLOWING THE SURGERY, HE REJECTED THE SUTURES AND EXPERIENCED A SEPARATION OF THE WOUND. THE PATIENT WAS THEN STARTED ORAL ANTIBIOTICS. ON (B)(6) 2013, THE SURGEON REMOVED THE SUTURES. IT WAS NOTED THAT SOME SUTURES WERE SURROUNDED BY PUS FILLED SACS. THE AREA WAS WASHED WITH NORMAL SALINE AND AN ANTIBIOTIC WASH. THE WOUND WAS RECLOSED WITH A DIFFERENT SUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330675 VICRYL SUTURE, ABSORBABLE GAM ETHICON INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention