BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHICON

    MDR report key: 1908869 · Received November 20, 2010

    Report

    Report Number
    MW5018280
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    January 12, 2004
    Report Date
    November 20, 2010
    Manufacturer
    ETHICON
    Product Code
    GAR
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    SURGICAL PROCEDURE TO REPAIR VENTRAL INCISIONAL HERNIA. INFECTION APPEARED W/I ONE WEEK OF PROCEDURE. USE OF SEVERAL ANTIBIOTICS, INFECTION PERSISTED. SECOND SURGERY OF (B)(6), 2004, EXPLORATION OF WOUND, REMOVAL OF MULTIPLE INFECTED SUTURES, DEBRIDEMENT, DRAINAGE AND PACKING OF ABSCESS. INFECTION CONTINUES, THIRD SURGERY, RECURRENT SUTURE ABSCESS, RECURRENT SUPRAUMBILICAL HERNIA. A SUTURE NOT REMOVED DURING SECOND SURGERY, IT WAS REMOVED AT THIS TIME AND INFECTION WENT AWAY. ETHICON NUROLON SUTURES WERE USED, POST OP REPORTS - 1 AND 2 - STATE ETHICON VICRYL AND MONOCRYL SUTURES. ETHICON DENIES RESPONSIBILITY AND CLAIMS THAT ALL TAINTED PRODUCTS WERE RETURNED. THERE IS NO DATE AVAILABLE FOR SPECIFIC RECALL INFO. ANTIBIOTICS: CEPHALEXIN, AMOX. TR-K, 875/25, LEVAQUIN 500, LEVAQUIN-IV -(B)(6), AMOX TR-K 875-125, LEVAQUIN 500, LEVAQUIN IV - (B)(6), AMOX TR-K 500, CEPHALEXIN 500.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETHICON NOROLON SUTURES GAR ETHICON
    2 ETHICON VICRYL SUTURES GAM ETHICON
    3 ETHICON MONOCRYL SUTURES GAN ETHICON

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization