BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL SUTURE

    MDR report key: 3161606 · Received June 7, 2013

    Report

    Report Number
    MW5030466
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    April 17, 2013
    Report Date
    June 7, 2013
    Manufacturer
    ETHICON INC, SUBSIDARY OF JOHNSON AND JOHNSON
    Product Code
    GAM
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT REPORTED HE HAD BEEN IMPLANTED WITH MANY SUBCUTANEOUS VICRYL SUTURES DURING A ROTATOR CUFF REPAIR SURGERY ON (B)(6) 2013. HE STATED THE SUTURES WERE SUPPOSED TO CAUSE A MILD REACTION WHICH WOULD TRIGGER THE BODY TO ABSORB THE SUTURE. HE ALLEGED THAT THEY HAD NOT RE-ABSORBED AS PROMISED BUT INSTEAD THE PT EXPERIENCED A REJECTION PHENOMENON. HE ALLEGED THAT TWO WEEKS AFTER SURGERY, THERE WAS A SEPARATION AND HIS PHYSICIAN STARTED HIM ON ORAL ANTIBIOTICS AS A PRECAUTIONARY MEASURE. ON (B)(6) 2013, HIS SURGEON DECIDED TO REMOVE THE SUTURES. DURING THE SURGERY, HE FOUND FLUID FILLED SACS SURROUNDING EACH SUTURE. SOME WERE FILLED WITH A CLEAR FLUID AND OTHERS WITH PUS. THE PT STATED THAT THE SURGEON COULD NOT BE SURE THAT HE REMOVED ALL OF THE SUTURES BUT WASHED THE AREA WITH NORMAL SALINE AND ANTIBIOTIC WASH SEVERAL TIMES. THE SURGEON REPLACED THE ORIGINAL SUTURES WITH DIFFERENT SUTURES. THE PT IS STILL IN THE PROCESSES OF HEALING FROM THAT SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252351 VICRYL SUTURE ABSORBABLE SUTURE GAM ETHICON INC, SUBSIDARY OF JOHNSON AND JOHNSON

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention