BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFORCE REINFORCEMENT MESH (FORTAFLEX MESH)

    MDR report key: 4093561 · Received September 3, 2014

    Report

    Report Number
    1221816-2014-00005
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    July 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ORGANOGENESIS, INC.
    Product Code
    FTM
    PMA / PMN Number
    042809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADHESIONS WERE PRESENT UPON THE INITIAL INCISION AND THIS LED TO A DECISION TO ALSO USE TENOGLIDE TENDON PROTECTOR. A NON ABSORBABLE SUTURE WAS ALSO USED TO ATTACH INFORCE TO TENDON FOR STRENGTH REINFORCEMENT. TENOGLIDE WAS CUT TO FIT UNDER AND OVER TENDONS. A CULTURE WAS PERFORMED AT THE SURGICAL SITE TO INVESTIGATE THE CONCERN OF SUSPECTED INFECTION. A CULTURE WAS TAKEN AND THERE WAS NO REPORT OF MICROBIAL CONTAMINATION. AT SUBSEQUENT FOLLOW UP VISITS, THE PATIENT APPEARED TO BE "DOING BETTER AND THE SOFT TISSUES ARE SETTLING DOWN." THE AVAILABLE INFO FOR THIS MEDICAL EVENT WAS REVIEWED BY DR. (B)(4), ORGANOGENESIS INC. ON (B)(4) 2014. THE EDEMA AND ERYTHEMA OBSERVED WAS DESCRIBED AS SEVERE AND PHOTOGRAPHIC EVIDENCE SUPPORTS THIS STATEMENT; HOWEVER, THIS PATIENT WAS NOT HOSPITALIZED AND THERE WERE NO REPORTED MEDICAL OR SURGICAL INTERVENTIONS. THE EDEMA AND ERYTHEMA ORIGINALLY REPORTED WAS OBSERVED TO SUBSTANTIALLY RESOLVE. THE CAUSE OF EDEMA AND SUSPECTED INFECTION WERE APPARENTLY NOT DUE TO ANY SIGNIFICANT BIOBURDEN SINCE MICROBIAL CULTURES OF THE SURGICAL SITE SHOWED NEGATIVE RESULTS. FURTHERMORE, THE PATIENT'S TENDONS WERE DESCRIBED AS BEING IN "POOR QUALITY" PRIOR TO INFORCE APPLICATION. ADHESIONS PRESENT DURING THE INITIAL INCISIONS ARE SUGGESTIVE OF PREVIOUS INJURY TO THE TENDON AND A HISTORY OF CONCOMITANT INFLAMMATORY EVENTS.

    Description of Event or Problem · 1

    ORGANOGENESIS WAS NOTIFIED OF THE EVENT ON (B)(6) 2014 VIA E-MAIL COMMUNICATION FROM CONTRACTUAL PARTNER. ON (B)(6) 2014 (B)(6), MED COMPLAINTS SPECIALIST, (B)(4), REPORTED ON BEHALF OF THE CUSTOMER, (B)(6) THAT A PATIENT ((B)(6) Y/O MALE) WHO HAD RECEIVED INFORCE WAS EXPERIENCING SEVERE SWELLING (EDEMA) AND REDNESS (ERYTHEMA) A WEEK AFTER APPLICATION. THE INITIAL APPLICATION OF INFORCE WAS ON (B)(6) 2014 AND THE SWELLING AND REDNESS WAS OBSERVED ON (B)(6) 2014 BY THE HAND THERAPIST. THE PHYSICIAN, DR (B)(6), WAS CONCERNED ABOUT THE REACTION AND POSSIBLE INFECTION DUE TO THE GRAFT. THE PATIENT WAS TREATED WITH ONE INFORCE UNIT ON (B)(6) 2014 FOR TENDON REPAIR OF THE LEFT WRIST. THIS UNIT WAS FROM INFORCE (LOT # 120612A), EXPIRATION DATE 11/30/2014. AS REPORTED BY THE SALES SPECIALIST (B)(6), IT WAS DISCOVERED DURING SURGERY THAT THE PATIENT'S TENDONS WERE OF POOR QUALITY. REINFORCEMENT WAS DETERMINED TO BE NECESSARY AND INFORCE WAS SELECTED. A NON-ABSORBABLE SUTURE WAS USED TO AFFIX INFORCE TO THE DAMAGED TENDON. TENOGLIDE WAS ALSO IN DIRECT CONTACT WITH THE TENDONS FOR SUPPORT BOTH ABOVE AND BELOW. THE PRESENCE OF INFECTION WAS NOT CONFIRMED BY MICROBIAL CULTURE. EDEMA IN THIS TYPE OF PROCEDURE IS TO BE EXPECTED; HOWEVER, THE SEVERITY OF THE REACTION SELDOM OCCURS. WHILE THERE IS NO OVERWHELMING EVIDENCE THAT THE USE OF INFORCE WAS RELATED TO THE EDEMA OBSERVED, THE POSSIBILITY OF RELATEDNESS EXISTS. ALSO TO BE CONSIDERED IS THAT ADDITIONAL PRODUCTS WERE IN CONTACT WITH THE TENDONS DURING SURGERY (NON ABSORBABLE SUTURE AND TENOGLIDE). IT IS THEREFORE, UNCLEAR WHETHER THE SEVERE REACTION THAT RESULTED WAS RELATED TO ANY OR ALL OF THE PRODUCTS USED IN THIS PROCEDURE. BASED UPON THE INFO PROVIDED, IT IS UNK WHETHER THE INFORCE GRAFT AND THE REPORTED MED EVENTS WERE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537304 INFORCE REINFORCEMENT MESH (FORTAFLEX MESH) SURGICAL MESH FTM ORGANOGENESIS, INC. IF120612A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other