BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN STRATTICE

    MDR report key: 15123318 · Received July 28, 2022

    Report

    Report Number
    1000306051-2022-00134
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    April 11, 2014
    Report Date
    July 28, 2022
    Product Code
    FTM
    PMA / PMN Number
    K070560
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LEGAL EVENT IS BEING REPORTED AS SERIOUS INJURY DUE TO THE REPORTED RECURRENCE WITH SURGICAL INTERVENTION. THE VALID LOT NUMBER ASSOCIATED WITH THIS EVENT WAS NOT REPORTED AND REMAINS UNKNOWN; THEREFORE AN INTERNAL INVESTIGATION INTO THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. NO STRATTICE DEVICES WERE RETURNED FOR EVALUATION. BASED ON THE LIMITED INFORMATION, INCLUDING NO IDENTIFICATION OF THE LOT NUMBER, AND WITHOUT RELEVANT PATIENT FACTORS, A RELATIONSHIP BETWEEN THE EVENT AND THE STRATTICE COULD NOT BE DETERMINED. DUE TO THE LEGAL PROCESS, IF ADDITIONAL INFORMATION IS MADE AVAILABLE DURING LEGAL PROCEEDINGS, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A LEGAL EVENT THAT A 34 YEAR OLD MALE PATIENT HAD HERNIA REPAIR SURGERY ON OR ABOUT (B)(6) 2013. DURING THE HERNIA REPAIR SURGERY, PLAINTIFF¿S SURGEON IMPLANTED A STRATTICE MESH; CATALOG NUMBER FOR THIS MESH IS 0816001 AND THE LOT NUMBER IS S11128-531. ON OR ABOUT (B)(6) 2014, THE PATIENT RETURNED TO THE HOSPITAL REPORTING ABDOMINAL DISTENTION AND PAIN. ON OR ABOUT (B)(6) 2014, THE PATIENT RETURNED FOR A SURGICAL REPAIR OF A RECURRENT INCISIONAL HERNIA. THE PATIENT UNDERWENT A COMPONENT SEPARATION, ADHESIONS WERE CUT, AND AN ADDITIONAL STRATTICE MESH WAS PLACED. THE RECORDS INDICATE THIS IS A LIFECELL STRATTICE FIRM MESH; CATALOG NUMBER 3030002 AND LOT NUMBER IS S11344-080. AFTER SURGERY, THE PATIENT RETURNED TO THE HOSPITAL ON OR ABOUT (B)(6) 2014, REPORTING ABDOMINAL PAIN AND CELLULITIS. HE WAS DIAGNOSED WITH A LEFT SIDE ABDOMINAL WALL ABSCESS. AN INCISION AND DEBRIDEMENT WERE PERFORMED AND WOUND VAC WAS PLACED. ON OR ABOUT (B)(6) 2014, THE PATIENT UNDERWENT EXPLORATION AND DRAINAGE OF ABDOMINAL WALL ABSCESS AND REMOVAL OF FOREIGN BODY. HE UNDERWENT WOUND VAC PLACEMENT ON OR ABOUT (B)(6) 2014. ON OR ABOUT (B)(6) 2016, THE PATIENT UNDERWENT SURGICAL REPAIR FOR A RECURRENT INCISIONAL HERNIA REPAIR. ADHESIONS WERE CUT AND ADDITIONAL MESH WAS PLACED. THIS RECORD IS ASSOCIATED WITH LOT S11344-080 IMPLANTED ON (B)(6) 2014. RECORD 2 OF 2. MULTIPLE DATE OF OCCURRENCES ARE REPORTED WITH (B)(6) 2014 BEING THE FIRST DATE OF INTERVENTION. IT WAS NOT REPORTED IF THE DEVICE WAS EXPLANTED DURING ANY OF THE ADDITIONAL PROCEDURES. THIS EVENT IS TO CAPTURE THE REMAINING COMPLICATIONS REPORTED OF "ABDOMINAL WALL ABSCESS", "RECURRENT INCISIONAL HERNIA REPAIR", "ADHESIONS WERE CUT". IT WAS NOT REPORTED OR CLARIFIED WHAT "REMOVAL OF FOREIGN BODY" IS REFERENCING, THEREFORE IT HAS BE ADDED AS "OTHER MEDICAL NDR" ALTHOUGH A LOT NUMBER WAS REPORTED, THE LOT NUMBER IS NOT VALID, THEREFORE THE LOT HAS BEEN ADDED AS "UNKNOWN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2322107 UNKNOWN STRATTICE MESH, SURGICAL FTM NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention