BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 7109631 · Received December 12, 2017

    Report

    Report Number
    2210968-2017-71731
    Event Type
    Injury
    Date Received
    December 12, 2017
    Report Date
    November 24, 2017
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. 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 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. CITATION: WORLD J SURG (2012) 36:2305¿2310. DOI 10.1007/S00268-012-1664-3.

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE "WOUND HEALING AFTER OPEN APPENDECTOMIES IN ADULT PATIENTS: A PROSPECTIVE, RANDOMISED TRIAL COMPARING TWO METHODS OF WOUND CLOSURE¿ THAT THE PURPOSE OF THIS STUDY WAS TO COMPARE THE SAFETY OF CLASSIC INTERRUPTED NONABSORBABLE SKIN CLOSURE TO CONTINUOUS INTRADERMAL ABSORBABLE SUTURES IN APPENDECTOMY WOUNDS IN ADULT PATIENTS. THE PATIENTS WERE RANDOMIZED INTO TWO WOUND CLOSURE GROUPS: GROUP A, INTRADERMAL CONTINUOUS ABSORBABLE MONOFILAMENT SUTURES AND GROUP NA NONABSORBABLE INTERRUPTED SUTURES. THE WOUNDS WERE EVALUATED AND/OR SUTURES REMOVED 7-9 DAYS POSTOPERATIVELY. WOUND COMPLICATIONS IN GROUP A INTRADERMAL CONTINUOUS ABSORBABLE SUTURES INCLUDED WOUND INFECTION REQUIRING DRAINAGE AND ANTIBIOTICS . THIS STUDY SHOWS THAT RUNNING INTRADERMAL ABSORBABLE SUTURES IS AS SAFE FOR CLOSING APPENDECTOMY WOUNDS AS TRADITIONAL INTERRUPTED, NONABSORBABLE SUTURES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    888598 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention