BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 8967363 · Received September 5, 2019

    Report

    Report Number
    2210968-2019-86627
    Event Type
    Injury
    Date Received
    September 5, 2019
    Report Date
    August 9, 2019
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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 FOLLOWING INFORMATION.  TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (MONOCRYL SUTURE) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (MONOCRYL SUTURE) USED IN THIS PROCEDURE? PATIENT DEMOGRAPHICS. CITATION: EUR J PLAST SURG (2017); DOI: 10.1007/S00238-017-1316-9. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE : COMPARISON OF PAIN, NAUSEA, AND COMPLICATIONS IN OUTPATIENT AND INPATIENT BREAST AUGMENTATION" AUTHORS : CARLOS WECK ROXO, ANA CLAUDIA, WECK ROXO, FERNANDO SERRA, DENISE DA MOTA, JOAO HENRIQUE SPAGOLLA PONTELLO, DANIEL LEAL, JOSE HOACIO ABOUDIB, FABIO X. NAHAS, CITATION: EUR J PLAST SURG (2017); DOI: 10.1007/S00238-017-1316-9. THE AIM OF THIS STUDY WAS TO COMPARE THE POSTOPERATIVE COMPLICATIONS, PAIN, NAUSEA AND SATISFACTION BETWEEN AN OUTPATIENT AND ON 24-H HOSPITALIZATION BASIS. THIS PROSPECTIVE, RANDOMIZED, INTERVENTIONAL, ANALYTIC STUDY INVOLVES 80 FEMALE PATIENTS UNDERGOING BREAST AUGMENTATION. THE PATIENTS WERE RANDOMLY ALLOCATED IN TWO GROUPS: IN HOSPITAL GROUP, 40 PATIENTS (AVERAGE AGE:28.5 YEARS; AGE RANGE: 22-31 YEARS; MEAN BMI: 22.1 KG/M2; BMI RANGE: 19-24 KG/M2) WILL REMAINED HOSPITALIZED AFTER 24 H AND IN OUTPATIENT GROUP, 40 PATIENTS (AVERAGE AGE: 28 YEARS; AGE RANGE: 20-33 YEARS; MEAN BMI: 21.35 KG/M2; BMI RANGE: 20-23 KG/M2) WILL BE DISCHARGED AFTER THE SURGERY. INFRAMAMMARY INCISION WITH SUBGLANDULAR PLANE DISSECTION WAS PERFORMED IN ALL PATIENTS. THE POCKET WAS CREATED UNDER DIRECT VISUALIZATION, WITHOUT BLUNT DISSECTION, WITH A LED-LIGHTED RETRACTOR FOLLOWED BY VIGOROUS HEMOSTASIS. SUBDERMAL AND INTRADERMAL OF THE SKIN WAS CLOSED WITH MONOCRYL 3.0 (ETHICON) AND MONOCRYL 4.0 (ETHICON) RESPECTIVELY. REPORTED COMPLICATIONS IN THE HOSPITAL GROUP INCLUDED HEMATOMA (N-1) WHICH WAS TREATED CONSERVATIVELY, AND POSTOPERATIVE PAIN (N-40). IN OUTPATIENT GROUP, REPORTED COMPLICATIONS INCLUDED SUPERFICIAL WOUND INFECTION (N-1) WHICH WAS TREATED WITH ORAL ANTIBIOTIC THERAPY, AND POSTOPERATIVE PAIN (N-40). IN CONCLUSION, BREAST AUGMENTATION PERFORMED IN AN OUTPATIENT SETTING PRESENTED COMPLICATION RATES SIMILAR TO CONVENTIONAL HOSPITALIZATION, AS WELL AS LEVELS OF POSTOPERATIVE PAIN AND NAUSEA. HOWEVER, THERE WAS A HIGHER RATE OF PATIENT¿S SATISFACTION IN THE OUTPATIENT GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760968 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention