BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERI-GUARD PERICARDIUM WITH APEX PROCESSING

    MDR report key: 3821228 · Received May 20, 2014

    Report

    Report Number
    2032282-2014-00074
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 9, 2014
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    FTM
    PMA / PMN Number
    K983162
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER SYNOVIS COMPLETED THE INVESTIGATION. COMPANION SAMPLES WERE AVAILABLE FOR EVALUATION. COMPANION SAMPLES WERE NOT SENT TO MANUFACTURING FACILITY FOR EVALUATION PER BAXTER SYNOVIS REQUEST AS THE CASES WERE DETERMINED TO BE AN OFF-LABEL USE DURING THE PROCEDURE AND NOT NECESSARY FOR THE INVESTIGATION. BATCH REVIEW WAS PERFORMED FOR THE TWO SUSPECTED LOT NUMBERS THAT WERE INVOLVED IN THE CASE AND IT WAS DETERMINED NO ISSUES WERE REPORTED IN THE PROCESSING OF THE LOTS; ALL RELEASED PRODUCT MET TESTING SPECIFICATIONS AND REQUIREMENTS. NO TREND WAS IDENTIFIED. PER BAXTER SYNOVIS, NO FURTHER INVESTIGATION IS NECESSARY. MULTIPLE ATTEMPTS WERE TO RETRIEVE ADDITIONAL CASE INFORMATION, HOWEVER NONE WAS PROVIDED BY THE CUSTOMER. BAXTER ITALY SALES REP RE-TRAINED THE SURGEON ON THE APPROPRIATE USE OF THE PRODUCT AS PER IFU. THIS CASE WILL BE KEPT ON FILE FOR TRENDING PURPOSES.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER MEDICAL ASSESSMENT: PERI-GUARD IS INDICATED FOR USE AS PROSTHESIS FOR PERICARDIAL CLOSURE AND SOFT TISSUE DEFICIENCIES, WHICH INCLUDE: DEFECTS OF THE ABDOMINAL AND THORACIC WALL, HERNIAS (DIAPHRAGMATIC, FEMORAL, INCISIONAL, INGUINAL, LUMBAR, PARACOLOSTOMY, SCROTAL AND UMBILICAL), AND INTRACARDIAC AND GREAT VESSEL REPAIR. PERI-GUARD IS NOT INDICATE FOR VAGINAL USE, GIVEN THAT IN THIS ANATOMICAL AREA CONTAMINATION IS EXTREMELY LIKELY. GIVEN THE NON-INDICATED USE OF THE COLLAGEN MATRIX WE CANNOT EXCLUDE THAT THE IMPLANT HAS CAUSED OR CONTRIBUTED TO THE REPORTED COMPLICATIONS. BAXTER ITALY IS CURRENTLY FOLLOWING UP WITH THE CUSTOMER TO RETRIEVE ADDITIONAL INFORMATION AND COMPANION SAMPLE(S). A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT AND EVALUATION OF THE ADDITIONAL INFORMATION AND SAMPLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM BAXTER (B)(6) ON (B)(4) 2014: I HAVE RECEIVED FROM THE CUSTOMER THE RETURN OF THE UNITS OF THE PRODUCTS THAT THEY DIDN¿T USE: 5 UNITS OF BATCH 5803497-1854875, 2 UNITS OF BATCH 5803497-1854874. THESE ARE THE BATCHES THEY HAD IN HOUSE, SO THEY SHOULD BE THE BATCHES INVOLVED IN THE CASES. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 1

    CASE 5 OF 5: IT WAS REPORTED FROM BAXTER ITALY SALES REP THAT A SURGEON WOULD LIKE TO RETURN PERI-GUARD BECAUSE HE HAD FIVE (5) VAGINAL EROSION AND GRANULOMA CASES. NO FURTHER INFORMATION PROVIDED. COMPANION SAMPLE MAY BE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300255 PERI-GUARD PERICARDIUM WITH APEX PROCESSING MESH, SURGICAL FTM SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other