BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT

    MDR report key: 11228554 · Received January 26, 2021

    Report

    Report Number
    2210968-2021-00681
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    July 2, 2020
    Report Date
    January 11, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT PC (B)(4). COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED HEALTH EFFECT-CLINICAL CODES: E1703,E2327,E171601,E2315,E0506,E172001,E2006,E2338,E1906 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. 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 THAT ETHICON PRODUCTS (MERSILENE SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (PINNA INFECTION (N=6), ERYTHEMA, SWELLING AND BLISTERING (N=14), BLEEDING (N=1), SUTURE BREAKAGE/EXTRUSION (N=8), SKIN NECROSIS (N=1), ABSCESS OR PERSISTENT DISCHARGE AND SUTURE BREAKAGE/EXTRUSION(N=8)) DESCRIBED IN THE ARTICLE? PLEASE SPECIFY. -DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (MERSILENE SUTURE) USED IN THIS PROCEDURE? -IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (PINNA INFECTION (N=6), ERYTHEMA, SWELLING AND BLISTERING (N=14), BLEEDING (N=1), SUTURE BREAKAGE/EXTRUSION (N=8), SKIN NECROSIS (N=1), ABSCESS OR PERSISTENT DISCHARGE AND SUTURE BREAKAGE/EXTRUSION(N=8)). PLEASE SPECIFY MEDICAL/SURGICAL INTERVENTION PROVIDED FOR EACH PATIENT WITH POST-OPERATIVE COMPLICATIONS (PINNA INFECTION (N=6), ERYTHEMA, SWELLING AND BLISTERING (N=14), BLEEDING (N=1), SUTURE BREAKAGE/EXTRUSION (N=8), SKIN NECROSIS (N=1), ABSCESS OR PERSISTENT DISCHARGE AND SUTURE BREAKAGE/EXTRUSION(N=8)) PLEASE CLARIFY IF THERE WERE ANY PATIENT CONSEQUENCES IN CASES WITH SUTURE BREAKAGE POST-OP? IF YES, PLEASE SPECIFY. -WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CITATION: INTERNATIONAL JOURNAL OF PEDIATRIC OTORHINOLARYNGOLOGY 137 (2020) 110246 HTTPS://DOI.ORG/10.1016/J.IJPORL.2020.110246 PLEASE SEE ARTICLE ATTACHED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. CASES WITH ADVERSE EVENTS WERE SUBMITTED VIA 2210968-2021-00681 CASES WITH BREAKAGE SUTURE POST-OP WERE SUBMITTED VIA 2210968-2021-00682

    Description of Event or Problem · 1

    TITLE: OUTCOMES AND COMPLICATIONS OF INCISIONLESS OTOPLASTY ¿ A RETROSPECTIVE OBSERVATIONAL STUDY AND A REVIEW OF THE LITERATURE THE AIM OF THIS RETROSPECTIVE STUDY IS TO DETERMINE THE SAFETY AND EFFICACY OF INCISIONLESS OTOPLASTY IN THE AUTHOR¿S UNIT. BETWEEN 2008 AND 2017, 32 PATIENTS (N=20 FEMALE AND N=12 MALE WITH A MEDIAN AGE OF 9.9 YEARS) UNDERWENT BILATERAL AND UNILATERAL INCISIONLESS OTOPLASTY TO CORRECT PROMINENT EARS. DURING THE PROCEDURE, MERSILENE 3-0 SUTURES (ETHICON) WERE USED FOR PERCUTANEOUS PLACEMENT FOR MUSTARDE SUTURES VIA A POSTERIOR APPROACH TO CREATE THE NEO-ANTIHELIX AND MEDIALISE THE PINNA. POST-OPERATIVE COMPLICATIONS INCLUDE PINNA INFECTION (N=6), ERYTHEMA, SWELLING AND BLISTERING (N=14), BLEEDING (N=1), SUTURE BREAKAGE/EXTRUSION (N=8), SKIN NECROSIS (N=1). THE INFECTIONS WERE LOCALISED AND RELATED TO THE SUTURES. FIVE PATIENTS UNDERWENT REOPERATION TO REMOVED SUTURES AS A RESULT OF LOCAL STITCH ABSCESS OR PERSISTENT DISCHARGE. IN ONE PATIENT, THE INFECTION WAS FURTHER COMPLICATED BY SKIN NECROSIS, WHICH WAS MANAGED BY BILOBED FLAP. IT IS UNCLEAR WHY THEY EXPERIENCED A HIGH RATE OF INFECTION; SOME OF THESE CASES MAY BE INCLUSION CYSTS AND NOT TRUE BACTERIAL INFECTION. THE AUTHORS ALSO USED AN INTRAOPERATIVE DOSE OF INTRAVENOUS ANTIBIOTICS WHEN THEY NOTED POTENTIAL INCREASED INFECTION RISK. SUTURE BREAKAGE MAY BE RELATED TO THE SUTURE MATERIAL, THE STIFFNESS OF CARTILAGE OR TENSION USED IN SUTURE PLACEMENT. THE ERYTHEMA, SWELLING AND BLISTERING OF THE PINNA OCCURRED TYPICALLY 24 HOURS POSTOPERATIVELY. THE CAUSE OF THIS INFLAMMATORY SWELLING REMAINS UNCLEAR. THE SWELLING AND ERYTHEMA RESOLVED IN ALL PATIENTS AND NO SIGNIFICANT DEFORMITY OR SKIN CHANGES OCCURRED AS A RESULT. INCISIONLESS OTOPLASTY WAS ASSOCIATED WITH HIGH SUCCESS AND SATISFACTION RATES. A PREVIOUSLY UNDESCRIBED COMPLICATION OF EARLY POSTOPERATIVE ERYTHEMA, SWELLING AND BLISTERING MAY BE UNIQUE TO THIS TECHNIQUE. THIS PROCEDURE SHOULD BE FURTHER EVALUATED TO IDENTIFY RISK FACTORS AND PREVENTATIVE MEASURES TO REDUCE COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127912 MERSILENE POLYESTER FIBER SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention