BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7919188 · Received September 28, 2018

    Report

    Report Number
    2210968-2018-76153
    Event Type
    Injury
    Date Received
    September 28, 2018
    Report Date
    September 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WAS THE CASE DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? CITATION: EUR ORTHOP TRAUMATOL (2014) 5:187¿190; DOI 10.1007/S12570-013-0213-3 (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: SERRATIA MARCESCENS OSTEOMYELITIS IN THE HAND OF A NON-DEBILITATED, IMMUNOCOMPETENT WOMAN" AUTHOR(S): RICK J. FAIRHURST & LEO M. ROZMARYN CITATION: EUR ORTHOP TRAUMATOL (2014) 5:187¿190; DOI 10.1007/S12570-013-0213-3 THIS CASE REPORT AIMED TO PRESENT A (B)(6) FEMALE PATIENT WHO HAD TRAUMATIC LEFT THUMB AMPUTATION THROUGH THE PROXIMAL PHALANX WITH OPEN DISLOCATION THROUGH THE DISTAL INTERPHALANGEAL (DIP) JOINT OF THE LEFT INDEX FINGER UNDERWENT RECONSTRUCTION OF LEFT THUMB, REPAIR AND PINNING OF DIP JOINT AND TERMINAL EXTENSOR TENDON OF THE LEFT INDEX FINGER WHERE ETHIBOND SUTURES WERE USED. THREE MONTHS LATER, SHE PRESENTED SWELLING UNDER THE EPONYCHIAL FOLD ACCOMPANIED WITH CUTICLE LOSS AND DRAINAGE, TREATED WITH INCISION AND DRAINAGE OF EPONYCHIAL FOLD, WASHING AND PACKING OF WOUND WITH ANTIBIOTIC THERAPY OF AUGMENTIN® 875 MG PO BID × 14 DAYS. TWO DAYS LATER, EPONYCHIAL DRAINAGE HAD NOT ABATED, AND THE PATIENT WAS TAKEN TO THE OPERATING ROOM WHERE A HAIR MEASURING ABOUT 1 CM WAS FOUND. THE EPONYCHIAL FOLD WAS INCISED AND DRAINED, THE WOUND WAS WASHED OUT AND PACKED, AND THE OBLIQUE INCISIONS WERE SEWN WITH 6-0 PROLENE SUTURES. THERE WERE NO SIGNS OF INFECTION WHEN EXAMINING THE NAIL PLATE AND UNDERLYING SUBUNGUAL REGION, AND CULTURES WERE NEGATIVE. FIVE DAYS AFTER COMPLETING THE ANTIBIOTIC THERAPY, SHE EXPERIENCED A SIGNIFICANT INCREASE IN EPONYCHIAL DRAINAGE AS WELL AS FLUID TRACKING UNDER THE NAIL PLATE, RESULTING IN THE NAIL BECOMING SOFT FOR WHICH REMOVAL OF NAIL PLATE, DRAINAGE OF SUBUNGUAL ABSCESS WAS PERFORMED. THREE DAYS LATER, THERE WAS INCREASED EPONYCHIAL DRAINAGE, SUGGESTING THE POSSIBILITY OF GANGRENE OR OSTEOMYELITIS INVOLVING THE DISTAL END OF THE MIDDLE PHALANX, THE DISTAL PHALANX, AND THE DIP JOINT; AND MRI SHOWED DESTRUCTION OF THE DIP JOINT AS WELL AS OSTEOMYELITIS OF THE DISTAL PHALANX AND SUBCUTANEOUS FLUID COLLECTIONS AROUND THE DIP JOINT. SERRATIA MARCESCENS WAS CULTURED FROM THE DRAINAGE. THE PATIENT WAS TREATED WITH INTRAVENOUS AUGMENTIN AND SURGICAL EXPLORATION FOR WHICH TWO ETHIBOND SUTURES WERE FOUND AND REMOVED. THOROUGH DEBRIDEMENT OF THE PIP JOINT WAS PERFORMED AND SKIN FLAPS WERE LOOSELY CLOSED AND PACK WAS PLACED. A WET-TO-DRY DRESSINGS SOAKED IN DAKIN¿S SOLUTION TWICE DAILY WAS APPLIED. A PICC LINE WAS PLACED FOR A 6-WEEK COURSE OF CEFEPIME TO TREAT OSTEOMYELITIS. THE WOUND HEALED UNEVENTFULLY, AND THE NAIL PLATE BEGAN TO GROW. FIVE MONTHS POST-OPERATIVELY, THE PATIENT¿S FINGER WAS FOUND TO BE COMPLETELY HEALED WITH THE GROWTH OF A HEALTHY NAIL PLATE. THE SOURCE OF OUR PATIENT¿S S. MARCESCENS INFECTION CANNOT BE DEFINITIVELY ESTABLISHED, BUT POSSIBLE SOURCES INCLUDED EXPOSURE TO RIVER WATER AT THE TIME OF THE RAFTING ACCIDENT, NOSOCOMIAL CONTAMINATION OF THE SUTURES OR KIRSCHNER WIRE USED IN THE PINNING OF THE DISTAL PHALANX, AND PATIENT CONTAMINATION OF THE POST-OPERATIVE WOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    761465 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Required Intervention