BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7629072 · Received June 22, 2018

    Report

    Report Number
    2210968-2018-73680
    Event Type
    Injury
    Date Received
    June 22, 2018
    Report Date
    May 31, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. CITATION: THE JOURNAL OF LARYNGOLOGY & OTOLOGY (2013), 127, 76¿79. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE TITLE: NASAL TIP ABSCESS DUE TO ADVERSE SKIN REACTION TO PROLENE: AN UNUSUAL LONG TERM COMPLICATION OF RHINOPLASTY AUTHOR(S): A TEYMOORTASH, J A FASUNLA, W PFÜTZNER, S STEINBACH-HUNDT CITATION: THE JOURNAL OF LARYNGOLOGY & OTOLOGY (2013), 127, 76¿79; DOI: 10.1017/S0022215112002575. THIS PAPER AIMS TO DESCRIBE WHAT WE BELIEVE TO BE THE FIRST REPORTED CASE OF NASAL TIP ABSCESS WITH AN ADVERSE SKIN REACTION TO PROLENE FOLLOWING RHINOPLASTY. THE AUTHORS PRESENTED A (B)(6) FEMALE PATIENTS WHO UNDERGONE FUNCTIONAL SEPTO-RHINOPLASTY TO CORRECT BREATHING OBSTRUCTION CAUSED BY SHIFTED NASAL PYRAMID. SIX MONTHS AFTER THE PROCEDURE, THE PATIENT COMPLAINED SWELLING SENSATION AND RECURRENT FEELING OF PRESSURE AT THE NASAL TIP, BUT CLINICAL EXAM SHOWED NO PATHOLOGICAL FINDINGS. TWO YEARS POST SEPTO-RHINOPLASTY, THE PATIENT PRESENTED WITH PAINFUL, PROGRESSIVE NASAL TIP SWELLING AND REDNESS WHICH WAS TREATED INITIALLY WITH ENDONASAL DRAINAGE OF THE NASAL TIP ABSCESS, AND POST-OPERATIVE TREATMENT INCLUDING ANTISEPTIC DRESSINGS AND INTRAVENOUS ANTIBIOSIS WITH CEFUROXIME. REVISION OF RHINOPLASTY WAS PERFORMED, 3 MONTHS AFTER THE INITIAL ABSCESS DRAINAGE AND INTRA-OPERATIVE FINDINGS INCLUDED THIN NASAL TIP SKIN TETHERING TO THE UNDERLYING SUBCUTANEOUS TISSUE, AND GRANULATION TISSUE WITH INTERSPERSED POCKETS OF PUS AND KNOTTED PROLENE. THE KNOTTED PROLENE WAS REMOVED AND THE BED IRRIGATED COPIOUSLY WITH HYDROGEN PEROXIDE. THE PATIENT HAD IMPROVEMENT AND COMPLETE RESOLUTION OF SYMPTOMS WITH NO FURTHER COMPLAINTS DURING OVER ONE YEAR OBSERVATION. ADVERSE REACTION TEST WAS DONE AND PATCH TEST RESULT SHOWED NO REACTION TO PROLENE; HOWEVER, THE CUTANEOUS PROLENE SUTURE THAT WAS PLACED ON HER BACK SHOWED ERYTHEMATOUS INFILTRATE WITH PAPULES AND VESICLES AROUND THE SUTURE THREAD. USE OF NON-ABSORBABLE SUTURES, SUCH AS PROLENE, IN THE SUBCUTANEOUS LAYER MAY BE A POTENTIAL, RARE RISK FACTOR FOR ADVERSE SKIN REACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472380 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention