BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 2221932 · Received August 24, 2011

    Report

    Report Number
    2210968-2011-01166
    Event Type
    Injury
    Date Received
    August 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    ETHICON INC
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE TO REMOVE MOLES FROM THE LEFT LEG ABOUT TWO YEARS AGO AND SUTURE WAS USED. WHEN THE PATIENT RETURNED FOR SUTURE REMOVAL THE NURSE WAS UNABLE TO REMOVE ALL OF THE SUTURES. THE PATIENT WAS TOLD THE SUTURE WOULD DISSOLVE. APPROXIMATELY 3 MONTHS AFTER THE SURGERY THE PATIENT DEVELOPED CELLULITIS AND A PROSTATE INFECTION. THE PATIENT WAS TREATED WITH LEVAQUIN. IT TOOK SEVERAL MONTHS FOR THE INFECTION TO RESOLVE. THIS IS ONE OF TWO MEDWATCHES BEING SUBMITTED AS TWO DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2011-01605. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.

    Additional Manufacturer Narrative · 1

    DATE SENT TO THE FDA: (B)(4) 2011.(B)(4): NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN SURGICAL PROCEDURE AND SUTURE WAS USED. THE PATIENT EXPERIENCED A MASSIVE INFECTION ON AN UNKNOWN DATE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention