BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL (P0LYGLACTIN 910) SUTURE

    MDR report key: 540905 · Received August 27, 2004

    Report

    Report Number
    2210968-2004-00451
    Event Type
    Injury
    Date Received
    August 27, 2004
    Date of Event
    October 28, 1996
    Report Date
    August 16, 2004
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS ADMITTED AS AN OUTPT IN 1996 FOR A RIGHT INGUINAL HERNIA REPAIR WITH A MESH PRODUCT, AND WAS DISCHARGED WITHOUT COMPLICATION. AN ABSORBABLE SUTURE WAS USED. IN 10/1996 PT WAS ADMITTED WITH RIGHT INGUINAL CELLULITIS. PT HAD A HISTORY OF A RIGHT INGUINAL HERNIA REPAIR AND THERE HAD BEEN CHRONIC SWELLING POST-OPERATIVELY. FOUR WEEKS PRIOR TO ADMISSION THE PT NOTICED AN AREA OF DRAINAGE SO THEIR PHYSICIAN SUBSEQUENTLY PLACED THEM ON ANTIBIOTICS. THE ABSCESS HAD DECREASED IN SIZE HOWEVER PERSISTED AND PT WAS THEREFORE ADMITTED FOR FURTHER TREATMENT. PT WAS TAKEN TO THE O.R THE NEXT DAY FOR EXPLORATION AND EXCISION OF A CHRONIC SINUS TRACT AND REMOVAL OF INFECTED MESH. THE MESH WAS REMOVED IN IT'S "ONTIROTY" AND PT WAS TREATED WITH IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL (P0LYGLACTIN 910) SUTURE SUTURE, ABSORBABLE GAM ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention SURGIPRO MESH, 1996.