BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STRATTICE

    MDR report key: 2851512 · Received November 29, 2012

    Report

    Report Number
    1000306051-2012-00094
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    November 3, 2012
    Report Date
    November 3, 2012
    Manufacturer
    LIFECELL CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD OF EVALUATION: REVIEW OF INFORMATION REPORTED TO LIFECELL. REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT S10691. QUERY OF THE LIFECELL COMPLAINT SYSTEM FOR ANY OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST THIS LOT. REVIEW OF THE DEVICE DISTRIBUTION AND IMPLANTATION HISTORY RECORDS FOR LOT S10691. SINCE THE EXPLANTED DEVICE WAS DISCARDED BY THE HOSPITAL, NO EVALUATION WAS PERFORMED. RESULTS OF EVALUATION: REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT S10691 RESULTED IN NO REMARKABLE FINDINGS, WITH NO DEVIATIONS ASSOCIATED WITH THE NATURE OF THIS COMPLAINT. QUERY OF THE LIFECELL COMPLAINT SYSTEM AND REVIEW OF THE DEVICE DISTRIBUTION AND IMPLANTATION HISTORY REVEALED THAT AS OF (B)(4) 2012, 171 DEVICES WERE DISTRIBUTED, INCLUDING 52 DEVICES REPORTED AS IMPLANTED, WITH NO OTHER COMPLAINTS REPORTED TO LIFECELL AGAINST LOT S10691. CONCLUSION: BASED ON INFORMATION REPORTED, INCLUDING THE PATIENT'S PRE-OPERATIVE CONDITION, PHYSICIAN STATEMENTS AND INTERNAL INVESTIGATION INTO THE COMPLAINT-RELATED LOT, IT IS UNLIKELY THAT THE DEVICE CONTRIBUTED TO THE EVENT. THE PATIENT'S CO-MORBID CONDITION (COLLAGEN DISORDER) DIRECTLY CONTRIBUTED TO THE EVENT.

    Description of Event or Problem · 1

    A (B)(6) FEMALE PATIENT WITH AN UNDERLYING COLLAGEN DISORDER UNDERWENT AN INCISIONAL HERNIA REPAIR WITH THE DEVICE ON (B)(6) 2011. THE PATIENT WAS RE-OPERATED FOR A RECURRENT INCISIONAL HERNIA, ON (B)(6) 2012. IT WAS REPORTED THAT DURING THE REPAIR OPERATION, THE DEVICE WAS NOT INCORPORATED AND WAS REMOVED. THE INCISIONAL HERNIA WAS REPAIRED WITH ANOTHER PRODUCT. IT WAS REPORTED BY THE PHYSICIAN THAT THE NON-INCORPORATION LED TO THE SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STRATTICE MESH, SURGICAL FTM LIFECELL CORPORATION 2020002EU S10691-069

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention