BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 7375624 · Received March 27, 2018

    Report

    Report Number
    2210968-2018-71695
    Event Type
    Injury
    Date Received
    March 27, 2018
    Report Date
    March 9, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT THIS DEVICE EVENT IS NOT MALFUNCTION REPORTABLE THEREFORE, THIS MEDWATCH REPORT IS NOT REPORTABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE SENT TO THE FDA: 03/27/2018. (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. NO SPECIFIC PATIENT INFORMATION REGARDING EVENTS HAS BEEN PROVIDED. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. IF FURTHER DETAILS ARE RECEIVED AT THE 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. 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: MALAYSIAN ORTHOPAEDIC JOURNAL. 2013; 7 (1). DOI: HTTP://DX.DOI.ORG/10.5704.MOJ.1303.017.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: ¿TITLE: COMPARATIVE STUDY BETWEEN COAPTIVE FILM VERSUS SUTURE FOR WOUND CLOSURE AFTER LONG BONE FRACTURE FIXATION.¿ AUTHORS: IM ANUAR RAMDHAN, MBBS., W ZULMI, MS ORTH., AN HIDAYAH, MD., MJM KAMEL, MBBS., MSM FADHIL, MD., M ANWAR HAU, M MED ORTH. CITATION: MALAYSIAN ORTHOPAEDIC JOURNAL. 2013; 7 (1). DOI: HTTP://DX.DOI.ORG/10.5704.MOJ.1303.017. THE AIM OF THIS PROSPECTIVE, RANDOMIZED, CONTROLLED TRIAL WAS TO COMPARE THE COAPTIVE FILM WITH SUTURES FOR WOUND CLOSURE AFTER LONG BONE FRACTURE FIXATION INCLUDING, SKIN CLOSURE TIME, INCIDENCE OF WOUND COMPLICATIONS, AND SCAR WIDTH AT 12 WEEK FOLLOW-UP. A TOTAL OF 45 PATIENTS (AGE RANGE: 13 TO 33 YEARS OLD), UNDERWENT FEMORAL SHAFT FRACTURE FIXATION. OF WHICH, 22 PATIENTS HAD WOUND CLOSURE WITH SUTURES AND 23 PATIENTS HAD WOUND CLOSURE WITH COAPTIVE FILM. ALL PATIENTS UNDERWENT FEMORAL SHAFT FRACTURE FIXATION, EITHER PLATING OR NAILING, AND THE OPERATIVE WOUNDS WERE CLOSED IN LAYERS. THE DEEP FASCIAL LAYER WAS CLOSED WITH CONTINUOUS VICRYL 1 RUNNING SUTURE AND SUBCUTANEOUS LATER WAS CLOSED WITH AN ABSORBABLE BRAIDED VICRYL 0 SUTURE TO RELIEVE TENSION AND OPPOSE THE WOUND EDGES. ALL WOUNDS WERE CLOSED WITH THEIR RESPECTIVE SUTURE GROUPS. REPORTED COMPLICATION INCLUDED WOUND COMPLICATION IN 1 PATIENT FOR EACH GROUP WHICH WAS TREATED WITH LOCAL WOUND CARE. IT WAS CONCLUDED THAT THE USE OF COAPTIVE FILMS (STERI-STRIPS) FOR WOUND CLOSURE AFTER LONG BONE FRACTURE FIXATION IS A TIME-SAVING METHOD THAT CAN BE SAFELY USED WITHOUT ADDITIONAL RISK OF POSTOPERATIVE WOUND COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216561 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention