BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 2986113 · Received March 1, 2013

    Report

    Report Number
    1000306051-2013-00014
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 7, 2013
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: REVIEW OF INFORMATION REPORTED TO LIFECELL INCLUDING PATHOLOGICAL EVALUATION PROVIDED BY THE HOSPITAL. REVIEW OF THE DEVICE HISTORY RECORD FOR LOT S11076. QUERY OF THE LIFECELL COMPLAINTS SYSTEM FOR THE COMPLAINTS REPORTED AGAINST LOT S11076. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT S11076 (EXP. 02-2014) REVEALED NO REMARKABLE FINDINGS, WITH NO DEVIATIONS ASSOCIATED WITH THE NATURE OF THIS EVENT. QUERY OF LIFECELL COMPLAINT SYSTEM REVEALED THAT AS OF (B)(6) 2013, NO OTHER COMPLAINTS HAVE BEEN REPORTED TO LIFECELL AGAINST LOT S11076. AS OF (B)(6) 2013, 213 DEVICES WERE DISTRIBUTED FROM LOT S11076 INCLUDING, 136 DEVICES REPORTED AS IMPLANTED PER RETURNED TTRRS. CONCLUSION: BASED ON INFORMATION REPORTED INCLUDING PATIENT'S MEDICAL HISTORY AND INTERNAL INVESTIGATION INTO COMPLAINT RELATED LOT, IT IS UNLIKELY THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. THE LOT S11076 MET FOR QC CRITERIA FOR RELEASE OF THE FINISHED PRODUCT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO LIFECELL THAT ON (B)(6) 2012, A PATIENT UNDERWENT EXPLORATORY CELIOTOMY, ENTEROLYSIS, EXPLANTATION OF PREVIOUSLY PLACED MESH AND REPAIR A COMPLEX VENTRAL HERNIA WITH INCARCERATION; LIFECELL DEVICE WAS USED IN THIS PROCEDURE. ON (B)(6) 2013, THE WOUND OPENED IN THE MIDLINE, THE PATIENT WAS TAKEN TO THE O.R. AND THE DEVICE WAS EXPLANTED. IT WAS ALSO REPORTED THAT THE DEVICE DID NOT RUPTURE. THE DEVICE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89213 STRATTICE SURGICAL MESH FTM LIFECELL CORPORATION 2020002 S11076-022

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention