BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 10037843 · Received May 8, 2020

    Report

    Report Number
    2210968-2020-03799
    Event Type
    Injury
    Date Received
    May 8, 2020
    Report Date
    May 4, 2020
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE ADDITIONAL INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (PDS II SUTURE AND PROLENE SUTURE) INVOLVED? DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (PDS II SUTURE AND PROLENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER FOR EACH PATIENT? PATIENT DEMOGRAPHICS? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: CLINICAL OTOLARYNGOLOGY 43, 772¿773. ADVERSE EVENTS FOR PDS II SUTURE AND PROLENE SUTURE WERE SUBMITTED VIA 2210968-2020-03798. (B)(4).

    Description of Event or Problem · 1

    TITLE: PINNAPLASTY: IMPROVED ACCESS TO THE ANTIHELICAL FOLD THIS STUDY AIMED TO PRESENT THE PINNAPLASTY PROCEDURE WITH IMPROVED ACCESS TO THE ANTIHELICAL FOLD. A TOTAL OF OVER 100 EARS (50 PATIENTS) UNDERWENT PINNAPLASTY. IN THE PROCEDURE, THE SUTURES USE EXACTLY THE SAME PRINCIPLES AND HORIZONTAL MATTRESS TECHNIQUE OF THE MUSTARDE SUTURES BUT ARE PLACED THROUGH THE CARTILAGE FROM THE ANTERIOR SURFACE. THE AUTHOR¿S PREFERENCE WAS TO SCORE THE CARTILAGE AND PLACE MUSTARDE SUTURES WITH 5-0 PDS (POLYDIOXANONE/ETHICON, ETHICON US, LLC., CUSTOMER SUPPORT CENTER, 4545 CREEK ROAD, CINCINNATI, OHIO 45242-2839. USA) ON A REVERSE CUTTING, 3/8 CIRCLE CURVED NEEDLE. THE FLAP CAN THEN BE RE-LAID OVER THE AUGMENTED ANTIHELIX AND THE INCISION CLOSED WITH A FINE NON-ABSORBABLE SUTURE SUCH AS 5-0 PROLENE (POLYPROPYLENE/ETHICON). IN THE REDUCTION OF THE CONCHAL¿MASTOID ANGLE, THE AUTHORS¿ PERSONAL PREFERENCE WAS THROUGH THE USE OF SOFT TISSUE REDUCTION AND PLACEMENT OF FURNAS CONCHAL¿MASTOID 3-0 PDS (POLYDIOXANONE/ ETHICON) SUTURES. OUTCOMES INCLUDED MILD POSTOPERATIVE INFECTIONS (N=3) USING THIS TECHNIQUE WITH NO SERIOUS COMPLICATIONS OF NECROSIS/DEFORMITY, UNILATERAL REVISION (N=3) AND BILATERAL REVISION (N=1). THIS TECHNIQUE, WHICH LIMITS DISSECTION TO ONLY ONE SURFACE OF THE CARTILAGE, GREATLY REDUCES THE RISKS OF CARTILAGE DEVASCULARISATION, NECROSIS AND DEFORMITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    502088 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention