BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II (POLYDIOXANONE) SUTURE

    MDR report key: 1033813 · Received April 24, 2008

    Report

    Report Number
    2210968-2008-00281
    Event Type
    Injury
    Date Received
    April 24, 2008
    Report Date
    March 25, 2008
    Manufacturer
    ETHICON, INC.
    Product Code
    GAN
    PMA / PMN Number
    N18331
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGEON REPORTS THAT THIS PATIENT PRESENTED WITH A PRE-EXISTING INFECTION RELATED TO DIVERTICULITIS. THE PATIENT'S PRE-EXISTING CONDITION IS DIRECTLY RELATED TO THE EVENT. THE SURGEON FURTHER REPORTS NO SUTURE INVOLVEMENT OR SUTURE RELATION TO THE EVENT. A FOLLOW-UP 3500A WILL BE SUBMITTED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT HER SURGICAL WOUND WOULD NOT HEAL FOLLOWING A COLON RESECTION PROCEDURE. PATIENT OPINES AN ALLERGY TO THE DEVICE. THE ATTENDING SURGEON REPORTS THAT THIS PATIENT PRESENTED WHILE A PRE-EXISTING CONDITION OF DIVERTICULITIS WITH ABDOMINAL INFECTION NECESSITATING COLON RESECTION. THE CASE WAS REPORTED AS "DEFINITELY CONTAMINATED" RESULTING FROM THE DIVERTICULITIS/ABDOMINAL INFECTION. THE PATIENT CONTINUED TO EXPERIENCE A CHRONIC WOUND INFECTION DIRECTLY ATTRIBUTED TO THE PRE-EXISTING INFECTION. THE PATIENT'S POST-OP CARE INVOLVED A RETURN TO SURGERY FOR WOUND DEBRIDEMENT AND ANTIBIOTIC THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PDS II (POLYDIOXANONE) SUTURE SUTURE, ABSORBABLE GAN ETHICON, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention