BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7164225 · Received January 4, 2018

    Report

    Report Number
    2210968-2018-70046
    Event Type
    Injury
    Date Received
    January 4, 2018
    Report Date
    December 26, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. WAS MONOCRYL SUTURE USED FOR THE ANASTOMOSIS? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCT INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE MONOCRYL SUTURE USED IN THIS PROCEDURE? ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR THE SUBJECTS OF THIS ARTICLE? IF SO, PLEASE ALSO INCLUDE: PATIENT INITIALS, INITIAL PROCEDURE DATE, PRE-EXISTING CONDITIONS, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. J BIOMED RES. 2015;29 (4)(4):326-331; DOI: 10.7555/JBR.29.20140080.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿DELORME'S OPERATION PLUS SPHINCTEROPLASTY FOR COMPLETE RECTAL PROLAPSE ASSOCIATED WITH TRAUMATIC FECAL INCONTINENCE¿ THAT SUTURE WAS USED FOR PATIENT EXPERIENCING SHORT, FULL-THICKNESS RECTAL PROLAPSE ASSOCIATED WITH TRAUMATIC FECAL INCONTINENCE WHO HAD BEEN ADMITTED TO (B)(6) HOSPITAL DURING THE PERIOD OF (B)(6) 2010-(B)(6) 2013. DELORME¿S PROCEDURE WITH OVERLAP SPHINCTEROPLASTY WAS PERFORMED AND RECURRENCE OF PROLAPSE AND IMPROVEMENT OF FECAL INCONTINENCE WAS ASSESSED AFTER 1, 3, 6 AND 12 MONTHS. THE MUCOSA WAS DISSECTED FROM THE MUSCULARIS LAYER AND THE EXPOSED MUSCULAR LAYER OF THE WALL OF THE RECTUM WAS THEN FOLDED BY PLACATING ABSORBABLE SUTURE AND THEN GENTLY TIED. EVENTUALLY, THE CUT ENDS OF THE MUCOSA WERE SUTURED TOGETHER. THE PROLAPSE WAS THEN REDUCED. THE PATIENT MAY HAVE EXPERIENCED THE FOLLOWING EARLY POSTOPERATIVE COMPLICATIONS OF SUPERFICIAL WOUND INFECTION, MINOR WOUND DEHISCENCE AND TREATED SUCCESSFULLY WITH CONSERVATIVE MEASURES. THE PATIENT MAY HAVE EXPERIENCED POSTOPERATIVE BLEEDING WITHIN THE FIRST 24 HOURS. BLEEDING WAS NOT CONTROLLED CONSERVATIVELY AND REQUIRED REOPERATION TO IDENTIFY THE SOURCE OF BLEEDING AND SECURE IT, WITH BLEEDER AT THE MUCOSAL ANASTOMOSIS. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6852 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention