BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 2802586 · Received October 24, 2012

    Report

    Report Number
    1000306051-2012-00089
    Event Type
    Injury
    Date Received
    October 24, 2012
    Date of Event
    September 24, 2012
    Report Date
    September 25, 2012
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF DEVICE HISTORY RECORDS FOR LOT S11058. QUERY OF THE LIFECELL COMPLAINT SYSTEM FOR ANY OTHER COMPLAINTS REPORTED AGAINST DEVICES DISTRIBUTED FROM LOT S11058. RESULTS: REVIEW OF DEVICE HISTORY RECORDS FOR THE COMPLAINT-RELATED LOT RESULTED IN NO REMARKABLE FINDINGS. PROCESSING RECORDS INDICATE THE LOT WAS STERILIZED WITHIN PROCESS PARAMETERS. THE LOT MET ALL QC RELEASE CRITERIA, INCLUDING BACTERIAL ENDOTOXIN. (B)(4). CONCLUSION: LIFECELL CONCLUDES THAT A SERIOUS INJURY OCCURRED; THE PATIENT UNDERWENT AN ADDITIONAL SURGERY TO REMOVE THE DEVICE. BASED ON INTERNAL INVESTIGATION, THE DEVICE MET QC CRITERIA AT THE TIME OF RELEASE. THE INFECTION IS UNLIKELY TO BE RELATED TO THE STRATTICE, BUT THE DEVICE AS A CONTRIBUTING FACTOR IN THE DEVELOPMENT OF INFECTION CANNOT BE RULED OUT. SEROMA OCCURRENCE IS A DOCUMENTED COMPLICATION ASSOCIATED WITH BREAST SURGERY INDEPENDENT OF THE USE OF SURGICAL MESH. DEVICE WAS NOT RETURNED TO LIFECELL.

    Description of Event or Problem · 1

    THE DEVICE WAS IMPLANTED ON (B)(6) 2012, DURING A LEFT BREAST UNILATERAL COSMETIC PROCEDURE WITH STRATTICE PLACEMENT TO LEFT MEDIAL CAPSULE; PATIENT HAD PALPATION OF IMPLANT MEDIALLY. THE PATIENT DEVELOPED A SEROMA AND THE PHYSICIAN INSERTED A DRAIN ON (B)(6) 2012. A CULTURE WAS TAKEN AND WAS POSITIVE FOR MRSA. PATIENT HAD A RED BREAST FOR ABOUT THREE WEEKS, LOCALIZED TO WHERE THE STRATTICE WAS IMPLANTED. PATIENT WAS STARTED ON DURACEF FOR PRE-OP ON (B)(6) 2012, THEN SWITCHED TO LEVAQUIN ON (B)(6) 2012 FOR 10 DAYS. THE STRATTICE WAS REMOVED ON (B)(6) 2012 AND A SECOND CULTURE TAKEN WAS POSITIVE FOR (B)(6). IT WAS REPORTED THAT THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 0608001 S11058-484

    Patients

    Seq Age Sex Outcome Treatment
    1 DURACEF| LEVAQUIN