BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

    MDR report key: 5071105 · Received September 11, 2015

    Report

    Report Number
    1416980-2015-35658
    Event Type
    Injury
    Date Received
    September 11, 2015
    Report Date
    October 13, 2015
    Manufacturer
    SYNOVIS SURGICAL INNOVATIONS
    Product Code
    DXZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THE PATIENT EXPERIENCED THE INGUINAL INFECTION ON AN UNSPECIFIED DATE IN THE TIMEFRAME OF YEAR 2000 TO 2009. THIS REPORT IS FROM LITERATURE ABSTRACT: VERMA, H., KTENIDIS, K., GEORGE, R.K., TRIPATHI, R. VACUUM-ASSISTED CLOSURE THERAPY FOR VASCULAR GRAFT INFECTION (SZILAGYI GRADE III) IN THE GROIN-A 10-YEAR MULTI-CENTER EXPERIENCE. INTERNATIONAL WOUND JOURNAL. 2014. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A DEEP INGUINAL INFECTION AFTER UNDERGOING A SURGERY IN WHICH VASCU-GUARD WAS USED. THE CAUSE OF THE INGUINAL INFECTION WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT HAD SURGERY FOR FEMORAL ENDARTERECTOMY AND PATCH PLASTY. ON AN UNREPORTED DATE, DESCRIBED AS GREATER THAN 30 DAYS POST PROCEDURE, THE PATIENT DEVELOPED A DEEP INGUINAL INFECTION (NOT FURTHER SPECIFIED). AS A RESULT, ON UNREPORTED DATES, THE PATIENT WAS TREATED WITH MULTIPLE WOUND DEBRIDEMENTS, GRAFT SALVAGE, SARTORIUS MYOPLASTY, UNSPECIFIED INTRAVENOUS ANTIBIOTICS (DOSES AND FREQUENCIES NOT REPORTED) AND VAC (VACUUM-ASSISTED CLOSURE) THERAPY UNTIL THOROUGH SURFACE HEALING WAS ACHIEVED. NO FURTHER INFORMATION REGARDING THE PATIENT'S OUTCOME WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601270 PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE DXZ SYNOVIS SURGICAL INNOVATIONS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention