BEUDAMED
    FDA Adverse Event Other Summary report: N

    BIOSORB SUTURE 6-0

    MDR report key: 807270 · Received January 19, 2007

    Report

    Report Number
    MW1041673
    Event Type
    Other
    Date Received
    January 19, 2007
    Date of Event
    January 12, 2007
    Report Date
    January 19, 2007
    Manufacturer
    ALCON LABORATORIES
    Product Code
    GAR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ALCON ACS BIOSORB ABSORBABLE SUTURE 6-0 SIZE. ITEM NUMBER 10380658631014, LOT NUMBER E4J0382. I HAVE USED THIS SUTURE SINCE IT CAME TO MARKET - OVER 7 YRS - , FOR THE PERFORMANCE OF ALL TYPES OF EYE MUSCLE SURGERY. IN THE PAST FEW WEEKS (SINCE OPENING A NEW BOX) I HAVE HAD MULTIPLE PTS WITH INTRAOPERATIVE EVIDENCE OF SUTURE STRETCHING REQUIRING MULTIPLE RE-TIES. THIS PARTICULAR PT UNDERWENT A STRAIGHTFORWARD MEDIAL RECTUS RESECTION OF 6.5 MM, WHICH IS A FAIRLY LARGE RESECTION THAT LEAVES THE MUSCLE UNDER ALMOST NO TENSION. I HAD TO DRAW UP AND RE-TIE THE SUTURE THREE TIMES BECAUSE IT KEPT STRETCHING AND ALLOWING THE MUSCLE TO SAG BACK FROM ITS INTENDED LOCATION. THE SUTURE BECAME VISIBLY ATTENUATED. FOR THE SECOND PART OF THE PROCEDURE INVOLVING A MUSCLE RESECTION, WHICH PLACED A LOT MORE TENSION ON THE SUTURES, I SWITCHED TO VICRYL 6-0 (WHICH I HAVEN'T USED IN YRS) AND HAD NO DIFFICULTY. I HAVE USED THE SAME TECHNIQUE FOR SCLERAL NEEDLE PASSAGE AND KNOT-TYING FOR YRS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSORB SUTURE 6-0 * GAR ALCON LABORATORIES * E4J0382

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Other