BEUDAMED
    FDA Adverse Event Summary report: N

    CONEXA

    MDR report key: 2213283 · Received August 16, 2011

    Report

    Report Number
    1000306051-2011-00026
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 16, 2011
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: REVIEW OF LIMITED INFORMATION REPORTED TO LIFECELL. RESULTS OF EVALUATION: NO MALFUNCTION/SERIOUS INJURY WAS REPORTED. DRAINAGE NOTED, UNKNOWN IF MEDICAL OR SURGICAL INTERVENTION OCCURRED. CONCLUSION: EVENT IS REPORTED DUE TO LACK OF INFORMATION AVAILABLE. LIFECELL REQUESTED THAT (B)(6) OBTAIN FURTHER INFORMATION. NO INFORMATION HAS BEEN PROVIDED TO DATE. LIFECELL WILL FILE A FOLLOW-UP REPORT IF NEW INFORMATION IS RECEIVED. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2011, LIMITED INFORMATION WAS REPORTED BY (B)(6), LIFECELL DISTRIBUTION PARTNER, AS FOLLOWS: WHITE DRAINAGE FROM WOUND. PROCEDURE, DATE AND LOT NUMBER OF LIFECELL DEVICE ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONEXA SURGICAL MESH FTM LIFECELL CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Other