BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (POLYGLACTIN 910) SUTURE

    MDR report key: 329328 · Received April 27, 2001

    Report

    Report Number
    2210968-2001-00191
    Event Type
    Injury
    Date Received
    April 27, 2001
    Date of Event
    March 22, 2001
    Report Date
    March 28, 2001
    Manufacturer
    ETHICON, INC., SAN ANGELO
    Product Code
    GHM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE SUTURES WERE USE IN A HYBRID TOTAL RIGHT HIP ARTHROPLASTY IN 2001. PATIENT RETURNED TO PHYSICIAN COMPLAINING OF BURNING OVER THE SITE OF THE INCISION. PATIENT PRESENTED WITH DRAINAGE FROM THE INCISION SITE AND DIFFICULTY STANDING FROM A SEATED POSITION. PATIENT RE-ADMITTED 2 MONTHS LATER AND WAS RE-OPERATED FOR DRAINAGE OF THE INCISION AND PLACED ON IV ANTIBIOTICS. PATIENT WAS DISCHARGED 5 DAYS LATER AND REMAINED ON IV ANTIBIOTICS. SUTURE REMOVAL WAS SCHEDULED FOR 13 DAYS POST RE-OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19441 COATED VICRYL (POLYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GHM ETHICON, INC., SAN ANGELO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention