BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 18768456 · Received February 23, 2024

    Report

    Report Number
    2210968-2024-01777
    Event Type
    Injury
    Date Received
    February 23, 2024
    Date of Event
    January 29, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. AN ATTEMPT HAS BEEN 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. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. H6 CLINICAL CODE: E2402 ¿ ASYMMETRICAL PORTION OF THE ONE AREOLA. CITATION: JOURNAL OF PLASTIC, RECONSTRUCTIVE & AESTHETIC SURGERY, (2023); 78 (XX): 75-81. HTTPS://DOI.ORG/10.1016/J.BJPS.2023.01.031.

    Description of Event or Problem · 0

    TITLE: USE OF A BIOLOGICAL SCAFFOLD IN THE CLEAVAGE AREA IN COMPLEX REVISION BREAST AUGMENTATION: A SURGICAL TECHNIQUE AND CASE SERIES. THIS WAS A RETROSPECTIVE CASE SERIES REVIEW OF 11 PATIENTS WHO UNDERWENT REVISION BREAST AUGMENTATION WITH THE USE OF THE BIOLOGICAL SCAFFOLDS IN THE MEDIAL CLEAVAGE AREA. THE MEAN AGE WAS 43 YEARS WITH A RANGE OF 29¿68 YEARS. APPROXIMATELY TWO-THIRDS OF THE PATIENTS (7/ 11) HAD TWO OR MORE PREVIOUS BREAST OPERATIONS, RANGING FROM TWO TO SIX PREVIOUS PROCEDURES. ALL REPLACEMENT BREAST IMPLANTS WERE ANATOMICAL-SHAPED, MEDIUM PROFILE, POLYURETHANE-COATED IMPLANTS. A COMPETITOR MESH WAS USED IN SIX PATIENTS. MASTOPEXY WAS PERFORMED IN 8/11 PATIENTS. 3/0 POLYDIAXONONE (ETHICON PDS II), 3/0 AND 4/0 POLYGLACTIN 910 (ETHICON VICRYL), DERMABOND® (ETHICON INC), 2/0 POLYGLACTIN 910 (ETHICON VICRYL), 3/0 POLIGLECAPRONE 25 (ETHICON MONOCRYL), 4/0 POLYGLACTIN 910 (ETHICON VICRYL), 5/0 POLIGLECAPRONE 25 (ETHICON MONOCRYL), DERMABOND PRINEO SKIN CLOSURE SYSTEM TAPE (ETHICON) WERE ALSO USED DURING THE SURGERY. 5/0 POLIGLECAPRONE 25 (ETHICON MONOCRYL) FOR THE SKIN AROUND THE NIPPLE. THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING EVENTS CANNOT BE RULED OUT AS COMPLAINTS: PATIENT INFORMATION: >46 YEAR OLD FEMALE 5/0 POLIGLECAPRONE 25 (ETHICON MONOCRYL) ASYMMETRICAL PORTION OF THE ONE AREOLA. TREATMENT: MINOR CORRECTION OF A SCAR ALONG THE EDGE OF THE AREOLAR. IN CONCLUSION, THEY BELIEVE THAT IN THIS SHORT PATIENT SERIES THEY HAVE INTRODUCED A NOVEL TECHNIQUE THAT SHOWS THAT BIOLOGICAL MESH CAN BE USED SAFELY TO IMPROVE THE MEDIAL CLEAVAGE AREA IN A SUBSET OF DIFFICULT REVISION BREAST AUGMENTATION CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212392 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Female Required Intervention