BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT

    MDR report key: 7417702 · Received April 10, 2018

    Report

    Report Number
    2210968-2018-72064
    Event Type
    Injury
    Date Received
    April 10, 2018
    Report Date
    March 21, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    NEW
    PMA / PMN Number
    N18331
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    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. CITATION: PLASTIC AND RECONSTRUCTIVE SURGERY. 2010; 125(3). DOI: 10.1097/(B)(4) - [(B)(4) - ROSEN 2010.PDF].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: USE OF ABSORBABLE RUNNING BARBED SUTURE AND PROGRESSIVE TENSION TECHNIQUE IN ABDOMINOPLASTY: A NOVEL APPROACH." AUTHORS: ALLEN D. ROSEN, M.D. CITATION: PLASTIC AND RECONSTRUCTIVE SURGERY. 2010; 125(3). DOI: 10.1097/(B)(4). THE STUDY EVALUATED THE OPERATIVE TIMES, CLOSURE COSTS, AND SAFETY OUTCOMES ASSOCIATED WITH BIDIRECTIONAL BARBED ABSORBABLE SUTURES COMPARED WITH STANDARD SUTURES WHEN USED FOR SOFT-TISSUE APPROXIMATION, INCLUDING FASCIAL REPAIR, IN PATIENTS UNDERGOING COSMETIC ABDOMINOPLASTY. A TOTAL OF 24 PATIENTS UNDERWENT ABDOMINOPLASTY AND WERE INCLUDED IN THE STUDY. OF WHICH, 12 PATIENTS UNDERWENT A STANDARD NON-BARBED SUTURES WITH DRAINS AND ABSORBABLE DEEP DERMAL STAPLES AND 12 PATIENTS UNDERWENT BARBED ABSORBABLE SUTURES WITHOUT DRAINS OR DERMAL STAPLES. IN THE STANDARD NON-BARBED SUTURE GROUP, FASCIAL PLICATION WAS PERFORMED USING SIZE PDS 0 SUTURES, THE PROGRESSIVE TENSION SUTURE USED WAS A PDS 2-0 SUTURE, THEN A SKIN STAPLER WAS USED FOR DEEP DERMAL APPROXIMATION, AND THE SUBCUTICULAR CLOSURE WAS PERFORMED WITH MONOCRYL 4-0 SUTURES. IN THE STANDARD NON-BARBED SUTURE GROUP, REPORTED COMPLICATIONS INCLUDED A SMALL SEROMA IN THE SUBXIPHOID REGION (N-1) WHICH WAS TREATED WITH PUNCTURE ASPIRATION AND FAT NECROSIS IN THE INFRAUMBILICAL REGION (N-1). IT WAS CONCLUDED THAT THE USE OF ABSORBABLE BIDIRECTIONAL BARBED SUTURES FOR REPAIR OF FASCIAL DEFECTS IN ABDOMINOPLASTY, INCLUDING FASCIAL PLICATION, PROGRESSIVE TENSION, AND LAYERED SKIN CLOSURE PROVIDES SATISFACTORY RESULTS; THUS, IT ELIMINATES THE NEED FOR REDUNDANT PERMANENT SUTURE MATERIALS AND KNOTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253929 PDS II POLYDIOXANONE SUTURE UNKNOWN PRODUCT SUTURE, SURGICAL, ABSORBABLE NEW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention