BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE

    MDR report key: 3033541 · Received April 3, 2013

    Report

    Report Number
    2210968-2013-03420
    Event Type
    Injury
    Date Received
    April 3, 2013
    Report Date
    March 15, 2013
    Manufacturer
    ETHICON, INC
    Product Code
    GAS
    PMA / PMN Number
    N12815
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - INFLAMMATION OCCURRED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    (B)(4): IT WAS REPORTED THAT THE PATIENT UNDERWENT THE PROCEDURE ON (B)(6) 2012. THE FIRST SYMPTOM OF INFLAMMATORY CONJUNCTIVA WAS TREATED WITH CORTICOSTEROID. WITHOUT ANY EFFICIENCY, AN INFECTION HAS BEEN DECLARED. CULTURES WERE PERFORMED. (B)(6) EYE INFECTION WAS DIAGNOSED. A RE-OPERATION WAS PERFORMED ON (B)(6) 2013 AND THE INFLAMMATORY MESH WAS REMOVED. NO DEFECT OF THE SUTURE WAS NOTICED DURING THE SECOND OPERATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT SURGERY FOR RETINAL DETACHMENT ON AN UNKNOWN DATE AND SUTURE WAS USED. APPROXIMATELY ONE MONTH FOLLOWING THE SURGERY, THE PATIENT EXPERIENCED AN INFLAMMATORY REACTION TO THE STITCHES. ADDITIONAL INFORMATION REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137503 MERSILENE POLYESTER FIBER SUTURE SUTURE, NON ABSORBABLE GAS ETHICON, INC NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other