BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STRATTICE

    MDR report key: 2476443 · Received March 5, 2012

    Report

    Report Number
    1000306051-2012-00018
    Event Type
    Malfunction
    Date Received
    March 5, 2012
    Date of Event
    January 26, 2012
    Report Date
    February 3, 2012
    Manufacturer
    LIFECELL CORPORATION, BRANCHBURG, NJ
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L DEVICE INFO: LOT# S10948-049; MODEL# 2020002; EXPIRATION DATE 11/30/2012; LOT# S10961-164; MODEL# 1010002; EXPIRATION DATE 11/30/2012; LOT# S11000-079; MODEL# 1620002; EXPIRATION DATE 02/28/2013. ADD'L DATE OF MANUFACTURE: LOT# S10948-049; MANUFACTURE DATE 06/09/2011; LOT# S10961-164; MANUFACTURE DATE 06/30/2011; LOT# S11000-079; MANUFACTURE DATE 09/21/2011; METHOD OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS AND REVIEW OF THE LIFECELL COMPLAINT SYSTEM FOR ANY OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THE DEVICES DISTRIBUTED FROM THESE LOTS. RESULTS OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS ASSOCIATED WITH THE NATURE OF THIS COMPLAINT. INCLUDING IN-PROCESSING TENSILE TESTING OF THE LOTS, THE PRODUCTS MET ACCEPTANCE CRITERIA FOR QC RELEASE. TO DATE, NO OTHER COMPLAINTS HAVE BEEN REPORTED TO LIFECELL AGAINST LOTS S10948, S10961 AND S11000. TO DATE,OF THE OF THE (B)(4) DEVICES PROCESSED FOR LOT S10948, (B)(4) DEVICES WERE DISTRIBUTED WITH (B)(4) DEVICES REPORTED AS HAVING BEEN IMPLANTED; OF THE (B)(4) DEVICES PROCESSED FOR LOT S10961, (B)(4) DEVICES WERE DISTRIBUTED WITH (B)(4) DEVICES REPORTED AS HAVING BEEN IMPLANTED; AND OF THE (B)(4) DEVICES PROCESSED FOR LOT S11000, (B)(4) DEVICES WERE DISTRIBUTED WITH (B)(4) DEVICES REPORTED AS HAVING BEEN IMPLANTED. CONCLUSION CODE: LARGE ABDOMINAL WALL DEFECTS REQUIRING A BRIDGE REPAIR ARE AT AN INCREASED RISK OF REHERNIATION. IT IS A POSSIBILITY THAT THE CONCOMITANT PATIENT FACTORS OF PROLONGED HICCUPS AND A CAPPED TRACHEOSTOMY MAY HAVE ALSO CONTRIBUTED TOWARD THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(4) 12, IT WAS REPORTED TO LIFECELL THAT THE PATIENT UNDERWENT ABDOMINAL RECONSTRUCTION ON (B)(6) 2011 AND STRATTICE WAS PLACED AS A BRIDGE. PATIENT WAS PLACED ON A WOUND VAC WITH ADAPTIC AND XEROFORM. THE DEVICE TORE ON (B)(6) 2012. THE PATIENT HAD HICCUPS FOR FIVE DAYS PRIOR TO TEAR AND THE PATIENT'S TRACHEOSTOMY WAS CAPPED. NO OTHER SYMPTOMS, SIGNS OF INFECTION AND NO PATIENT CO-MORBIDITIES. THE PATIENT WAS RETURNED TO SURGERY AND THE DEVICE WAS REMOVED EXCEPT WHERE IT HAD ADHERED TO THE BOWEL AND OMENTUM. THE PATIENT WAS TRANSFERRED TO ANOTHER FACILITY, SO CURRENT CONDITION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION, BRANCHBURG, NJ REFER TO SECTION H.10 REFER TO SECTION H.10

    Patients

    Seq Age Sex Outcome Treatment
    1