BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COATED VICRYL PLUS ANTIBACTERIAL SUTURE

    MDR report key: 703967 · Received April 25, 2006

    Report

    Report Number
    2210968-2006-00316
    Event Type
    Injury
    Date Received
    April 25, 2006
    Report Date
    March 30, 2006
    Manufacturer
    ETHICON, INC.
    Product Code
    GAM
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AT THIS TIME. K022715.

    Additional Manufacturer Narrative · 1

    RESULTS, CONCLUSION: IMPLANT SURGERY WAS PERFORMED ON SAMPLES RECEIVED FOR EVALUATION. THE RESULTS INDICATE THAT THE SAMPLES RETAINED 75.01% BREAKING STRENGTH RETENTION AT 21 DAYS POST-IMPLANTATION. NO DEVICE FAILURE DETECTED AND THE DEVICE WAS WITHIN SPECIFICATION FOR % BREAKING STRENGTH RETENTION.

    Description of Event or Problem · 1

    A PATIENT PRESENTED WITH A SURGICAL WOUND DEHISCENCE AT AN UNHSPECIFIED TIME FOLLOWING TOTAL KNEE SURGERY. THE PATINET WAS RETURNED TO THE OR FOR SURGICAL REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COATED VICRYL PLUS ANTIBACTERIAL SUTURE SUTURE, ABSORBABLE. GAM ETHICON, INC. NA UP7083

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention