BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7342656 · Received March 15, 2018

    Report

    Report Number
    2210968-2018-71461
    Event Type
    Injury
    Date Received
    March 15, 2018
    Report Date
    March 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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. 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. DOES THE SURGEON BELIEVE THAT MONOCRYL SUTURE CAUSED OR CONTRIBUTED TO THE PERSISTENT DRAINAGE / INFECTION? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (DERMABOND/ VICRYL ) CAUSED AND/OR CONTRIBUTED TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE, SPECIFICALLY: INFECTION / PERSISTENT DRAINAGE? IF YES, PROVIDE DETAILS OF EVENT AND SPECIFIC SUTURE PRODUCT CODE. CAN SPECIFIC PATIENT DEMOGRAPHICS BE PROVIDED FOR EACH OF THE SUBJECTS OF THIS ARTICLE? IF YES, PLEASE INCLUDE: DATE AND TYPE OF PROCEDURE, WHERE PROCEDURE WAS PERFORMED, SPECIFIC MEDICAL/SURGICAL INTERVENTION PER PATIENT, PRODUCT INVOLVED, PRE-EXISTING CONDITIONS. PRODUCT CODE AND LOT NUMBER OF PRODUCT USED? WERE ANY CULTURES PERFORMED? IF YES WHAT WAS THE RESULT?

    Description of Event or Problem · 1

    TITLE: A PROSPECTIVE RANDOMIZED COMPARISON OF 2 SKIN CLOSURE TECHNIQUES IN ACETABULAR FRACTURE SURGERY AUTHORS: CHRISTOPHER D. MUDD, JOHN A. BOUDREAU, BERTON R. MOED CITATION: J ORTHOPAED TRAUMATOL. 2014; 15:189 194. DOI: 10.1007/S10195-013-0282-7 THE PURPOSE OF THIS PROSPECTIVE CLINICAL STUDY WAS TO ANSWER THE FOLLOWING QUESTIONS: WILL CLOSURE OF A KOCHER-LANGENBECK (K-L) INCISION AFTER ACETABULAR FRACTURE SURGERY WITH A RUNNING SUBCUTICULAR MONOCRYL SUTURE, THEN SEALING THE WOUND WITH DERMABOND, RESULT IN A LOWER INFECTION RATE COMPARED TO METALLIC STAPLE CLOSURE? DO INCISIONS CLOSED WITH SUBCUTICULAR MONOCRYL AND DERMABOND EXHIBIT DECREASED DRAINAGE? AND IS THERE A COST DIFFERENCE BETWEEN THESE TWO METHODS? A TOTAL OF 103 PATIENTS WITH ISOLATED ACETABULAR FRACTURES UNDERWENT ACETABULAR FRACTURE SURGERY. OF WHICH, 51 PATIENTS UNDERWENT SUPERFICIAL CLOSURE OF THE K-L INCISION WITH A RUNNING SUBCUTICULAR MONOCRYL 3-0 SUTURE THEN SEALED WITH DERMABOND SKIN ADHESIVE AND 52 PATIENTS UNDERWENT SKIN CLOSURE WITH METALLIC STAPLES. DURING SURGERY, A STANDARD K-L SURGICAL APPROACH WITHOUT EXTENSION OR TROCHANTERIC OSTEOTOMY WAS USED IN ALL CASES. INTRAOPERATIVELY, ALL PATIENTS RECEIVED IDENTICAL DEEP CLOSURE OF THE FASCIA USING VICRYL 0 INTERRUPTED SUTURES AND MONOCRYL 2-0 INTERRUPTED SUBDERMAL SUTURES. IN THE SUPERFICIAL CLOSURE WITH RUNNING SUBCUTICULAR MONOCRYL SUTURE SEALED WITH DERMABOND GROUP, REPORTED COMPLICATIONS INCLUDED PERSISTENT DRAINAGE (N-21) WHICH REQUIRED VACUUM-ASSISTED DRESSINGS. IN THE SKIN CLOSURE WITH METALLIC STAPLES GROUP, REPORTED COMPLICATIONS INCLUDED A (B)(6) MALE WITH DEEP INFECTION AND A (B)(6) FEMALE WITH DEEP INFECTION WHICH WERE TREATED WITH MULTIPLE IRRIGATIONS, DEBRIDEMENT WITH DELAYED CLOSURE, AND ANTIBIOTIC BEADS AND PERSISTENT DRAINAGE (N-23) WHICH REQUIRED VACUUM-ASSISTED DRESSINGS. IT WAS REPORTED THAT THE RESULTS INDICATE THAT CLOSURE WITH SUTURE AND DERMABOND MAY CONFER A CLINICAL ADVANTAGE. THEREFORE, THE APPLICATION OF TOPICAL DERMABOND TO THE WOUND MAY PREVENT COLONIZATION THAT OCCURS POST-OPERATIVELY AND WITH ROUTINE DRESSING CHANGES. IT WAS CONCLUDED THAT CLOSURE WITH DERMABOND AND SUBCUTICULAR MONOCRYL SHOWED NO CLINICAL DISADVANTAGES AND APPEARS TO HAVE A CLINICAL ADVANTAGE WHEN COMPARED TO STANDARD METALLIC STAPLE SKIN CLOSURE IN ACETABULAR FRACTURE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185726 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention