BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 2230373 · Received September 1, 2011

    Report

    Report Number
    1000306051-2011-00033
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    September 2, 2011
    Report Date
    September 23, 2011
    Manufacturer
    LIFECELL
    Product Code
    FTM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION (TO BE SPECIFIED): REVIEW OF INFORMATION REPORTED TO LIFECELL. RESULTS OF EVALUATION (TO BE SPECIFIED): BASED ON INFORMATION AVAILABLE, EVENT, MALFUNCTION, THAT REQUIRED SURGICAL INTERVENTION CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. LIFECELL REQUIRED LOT NUMBER INFORMATION FROM THE USER FACILITY. LIFECELL WILL FILE FOLLOW-UP REPORT IF ADDITIONAL INFORMATION BECOMES AVAILABLE

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: - REVIEW OF THE INFORMATION REPORTED TO LIFECELL. - REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT S10876. - REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY SIMILAR COMPLAINTS REPORTED AGAINST THIS LOT. RESULTS OF EVALUATION: - REVIEW OF THE DEVICE HISTORY RECORDS RESULTED IN NO REMARKABLE FINDINGS, WITH NO DEVIATIONS RELATED TO THE NATURE OF THIS EVENT. (B)(4). CONCLUSION CODE : BASED ON INFORMATION REPORTED, THE EVENT WAS EVALUATED AS A MALFUNCTION OF THE DEVICE THAT WAS REPAIRED WITH ANOTHER LIFECELL DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT ON (B)(6) 2011, THE PATIENT UNDERWENT A VENTRAL HERNIA REPAIR WITH IMPLANTATION OF A LIFECELL DEVICE. DURING POST-OPERATIVE RESPIRATORY THERAPY, THE PATIENT SUFFERED A COUGHING EPISODE AND THEN NOTED A LARGE RIGHT SIDED ABDOMINAL BULGE. UPON SUBSEQUENT RE-OPERATION ON (B)(6) 2011 (POD 2), DEHISCENCE OF THE DEVICE AND FASCIA WAS FOUND AND REPAIRED WITH ANOTHER LIFECELL DEVICE. ORIGINAL DEVICE WAS LEFT IN PLACE. IT WAS REPORTED THAT THE PATIENT IS RECOVERING FROM SURGERY AND DOING GOOD.

    Description of Event or Problem · 1

    THIS IS A FOLLOW UP ON INITIAL REPORT FILED ON (B)(6) 2011 TO INCLUDE INVESTIGATION INTO COMPLAINT RELATED LOT. ON (B)(6) 2011, LIFECELL OBTAINED LOT NUMBER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL 1016002 S10876-186

    Patients

    Seq Age Sex Outcome Treatment
    1