BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 1883571 · Received October 26, 2010

    Report

    Report Number
    1000306051-2010-00014
    Event Type
    Malfunction
    Date Received
    October 26, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    LIFECELL CORPORATION, BRANCHBURG, NJ 08876
    Product Code
    FTM
    PMA / PMN Number
    N/A
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: (TO BE SPECIFIED): INSPECTION OF THE RETURNED DEVICE. REVIEW OF THE DEVICE HISTORY RECORD. REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THE DEVICES DISTRIBUTED FROM THIS LOT. RESULTS OF EVALUATION: DUE TO CONDITION OF THE DEVICE (RETURNED IN FORMALIN), ONLY VISUAL INSPECTION WAS POSSIBLE, WHICH WAS INCONCLUSIVE. REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO DEVIATIONS ASSOCIATED WITH THE NATURE OF THIS COMPLAINT. TO DATE, OF THE 193 DEVICES PROCESSED FOR LOT S10670, 145 DEVICES HAVE BEEN DISTRIBUTED WITH 13 DEVICES THAT WERE REPORTED AS HAVING BEEN IMPLANTED; ONE OTHER COMPLAINT REPORTED AGAINST THIS LOT THAT WAS EVALUATED AS UNRELATED TO THE DEVICE. CONCLUSION: NO CONCLUSION CAN BE DRAWN DUE TO LACK OF INFORMATION. LIFECELL WILL FILE FOLLOW UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT THE PATIENT, WITH A HISTORY OF FASCIAL DEHISCENCE AND FISTULA TAKEDOWN REPAIR, UNDERWENT ABDOMINAL WALL RECONSTRUCTION WITH THE DEVICE UTILIZED TO CLOSE OPEN ABDOMEN. ON POD 4, UPON REOPERATION, DEVICE WAS NOTICED TO BE PARTIALLY TORN AND REABSORBED; DEVICE WAS EXPLANTED. ABSORBABLE MESH WAS USED FOR REPAIR. THE PATIENT UNDERWENT SKIN GRAFTING AND HAS BEEN DISCHARGED HOME. DUE TO CONDITION OF THE GRAFT (RETURNED TO LIFECELL IN FORMALIN), ONLY VISUAL INSPECTION WAS POSSIBLE, WHICH WAS INCONCLUSIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION, BRANCHBURG, NJ 08876 1620002EU S10670-060

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR