BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 3801750 · Received May 9, 2014

    Report

    Report Number
    1000306051-2014-00031
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 3, 2014
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INTERNAL INVESTIGATION INTO COMPLAINT RELATED DEVICE INCLUDED THE FOLLOWING: -THE PRODUCT MET ACCEPTANCE CRITERIA FOR QC RELEASE INCLUDING MECHANICAL TESTING. -THERE WAS NO NON-CONFORMANCES OR DEVIATIONS OBSERVED DURING BATCH RECORD REVIEW RELATED TO THE EVENT REPORTED. - (B)(4). - AS PER QUERY OF COMPLAINT MANAGEMENT DATABASE, NO OTHER COMPLAINTS RELATED TO THE REPORTED EVENT HAVE BEEN REPORTED TO LIFECELL FOR LOT S11109. BASED ON INTERNAL INVESTIGATION INTO THE REPORTED LOT (NO COMPLAINTS REPORTED FOR THE LOT, REVIEW OF BATCH PROCESSING RECORDS) THE EVENT IS UNLIKELY RELATED TO THE STRATTICE. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    A FEMALE PATIENT PRESENTED WITH A RECURRENT HERNIA IN (B)(6) 2013. SHE HAD A HISTORY OF DIABETES AND MULTIPLE ABDOMINAL SURGERIES, INCLUDING RECURRENT RE-HERNIATION. SHE UNDERWENT A RECURRENT, INCISIONAL HERNIA REPAIR WITH STRATTICE; ON (B)(6) 2013. THE STRATTICE WAS PLACED AS AN UNDERLAY. THE PATIENT HAD A STRATTICE DEVICE PLACED IN A PRIOR HERNIA REPAIR SURGERY, ON (B)(6) 2012. THE DEVICE PLACED IN (B)(6) 2012, WAS REMOVED DURING THE (B)(6) 2013 PROCEDURE. (B)(6) 2014, THE PATIENT UNDERWENT A 3RD HERNIA REPAIR WITH PRIMARY CLOSURE ONLY (NO MESH), DUE TO A RECURRENT HERNIA. ACCORDING TO INFORMATION RECEIVED FROM SURGEON ON (B)(6) 2014, STRATTICE WAS DETACHED AND CAME LOOSE ON ONE SIDE; AND WAS REMOVED ON (B)(6) 2014. THREE CULTURES WERE TAKEN. THE SURGEON INDICATES THE STRATTICE DID NOT LOOK INFECTED, HOWEVER; THERE WAS A LOT OF INFLAMMATION AND A SMALL POCKET OF CLOUDY FLUID AROUND THE STRATTICE. THE CULTURE RESULTS WERE SWABS OF AN ABDOMINAL CAVITY ABSCESS AND 2 ABDOMINAL INCISION SWABS. THE ABSCESS CULTURE WAS POSITIVE FOR STAPH AUREUS. THE INCISION CULTURES WERE POSITIVE FOR HEAVY AND MODERATE GROWTH STAPH AUREUS. ACCORDING TO SURGEON THE DEVICE WAS NOT INFECTED AND HE DID NOT REMOVE THE DEVICE DUE TO INFECTION. THE PATIENT WAS ON ORAL ANTIBIOTICS AT TIME OF DISCHARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280786 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 1620002 S11109

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R