BEUDAMED
    FDA Adverse Event Injury Summary report: N

    6-0 VICRYL SUTURE WITH S-29 NEEDLE

    MDR report key: 980041 · Received January 16, 2008

    Report

    Report Number
    MW5004965
    Event Type
    Injury
    Date Received
    January 16, 2008
    Report Date
    January 16, 2008
    Manufacturer
    ETHICON, DIV OF J+J
    Product Code
    GAM
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    RPTR STATES THAT AT LEAST 20 OR MORE SURGEONS ACROSS THE U.S. HAVE EXPRESSED A CONCERN ABOUT THIS DEVICE. STATES THE EYE SUTURES THAT HE HAS PLACED ON PEDIATRIC PATIENTS HAS COME UNRAVELED. STATED THE LABELING USE TO SAY MANUFACTURED IN THE U.S., BUT NOW SAYS MANUFACTURED IN ANOTHER COUNTRY. STATED HE CALLED THE ETHICON REP. WITH THIS CONCERN, BUT FELT CONCERN WASN'T TAKEN SERIOUSLY. STATED THERE WAS A BLOG RUMOR ON THE INTERNET WHICH HE TOOK OFFENSE TO AS PROBLEM IS NOT BEING TAKEN SERIOUSLY. STATED HE HAS 6 SURGERIES SCHEDULED TOMORROW AND HE HAS TO USE AN ALTERNATE PRODUCT THAT HE IS NOT USED TO JUST BECAUSE HE DOESN'T TRUST/WON'T USE THIS ETHICON PRODUCT ANY MORE. STATED NURSE AT HOSPITAL, IS THE O.R. NURSE WHO KEPT THE SUTURE AND WANTS FDA TO CONTACT HER. STATED SHE EVEN HAS PHOTOS. RPTR WANTS FDA TO LOOK INTO THIS PROBLEM AS SURGEONS ARE USING THIS PRODUCT ON EYE MUSCLES OF CHILDREN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6-0 VICRYL SUTURE WITH S-29 NEEDLE NONE GAM ETHICON, DIV OF J+J

    Patients

    Seq Age Sex Outcome Treatment
    1 YR