BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 22201775 · Received June 13, 2025

    Report

    Report Number
    2210968-2025-06818
    Event Type
    Injury
    Date Received
    June 13, 2025
    Date of Event
    July 14, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (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. PATIENT DEMOGRAPHICS? D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: HTTP://PUBMED.NCBI.NLM.NIH.GOV/39370557/

    Description of Event or Problem · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: FAURSCHOU IK, SØRENSEN MJ, PEDERSEN AG, RASMUSSEN SL, ERICHSEN R, HAAS S. CLOSED-INCISION NEGATIVE-PRESSURE WOUND THERAPY AFTER BASCOM'S CLEFT LIFT SURGERY FOR PILONIDAL SINUS DISEASE: A RANDOMIZED STUDY COMPARING HEALING. COLORECTAL DIS. 2024 OCT 6;27(1):E17198. DOI: 10.1111/CODI.17198. EPUB AHEAD OF PRINT. PMID: 39370557; PMCID: PMC11683170. THE AIM OF THIS STUDY IS TO INVESTIGATE IF CLOSED-INCISION NEGATIVE-PRESSURE WOUND THERAPY (NPWT) PROMOTES WOUND HEALING AFTER BASCOM'S CLEFT LIFT (BCL) SURGERY FOR COMPLICATED PILONIDAL SINUS DISEASE COMPARED WITH CONVENTIONAL DRAINAGE AND DRESSING. BETWEEN JANUARY 2019 UNTIL APRIL 2022, 287 PATIENTS UNDERWENT BCL (BASCOM'S CLEFT LIFT) SURGERY. OF THESE, 175 WERE ELIGIBLE CANDIDATES AND 118 CONSENTED TO PARTICIPATE IN THE STUDY. PATIENTS WERE DIVIDED INTO TWO GROUPS; 60 PATIENTS HAD BEEN RANDOMIZED TO NPWT (NEGATIVE-PRESSURE WOUND THERAPY) AND 58 PATIENTS TO CONTROLLED GROUP. IN THE CONTROLLED GROUP PDS¿ 3.0 WAS PLACED TO A LOOP VESSEL DRAIN, WHILE MONOCRYL¿ 3.0 WAS USED TO CLOSE THE SKIN INTRADERMALLY. IN NPWT GROUP, THE MIDLINE SUBCUTANEOUS FAT WAS SUTURED WITH PDS¿ 3.0. THE DERMIS WAS SUTURED WITH INTERRUPTED INVERTED PDS¿ 3.0 SUTURES AND THE SKIN CLOSED USING NON-INTERRUPTED MONOCRYL¿ 3.0. SUTURES INTRADERMALLY. REPORTED COMPLICATIONS ARE: N=53 NOT HEALED; 2 WEEKS POST SURGERY (NPWT GROUP). N=51 NOT HEALED; 2 WEEKS POST SURGERY (CONTROL GROUP). N=15 NOT HEALED; 12 WEEKS POST SURGERY (NPWT GROUP). N=13 NOT HEALED; 12 WEEKS POST SURGERY (CONTROL GROUP). N=15; PROLONGED HEALING (NPWT GROUP). N=13; PROLONGED HEALING (CONTROL GROUP). N=4; RECURRENCE (NPWT GROUP). N=1; RECURRENCE (CONTROL GROUP). N=?; UNSPECIFIED COMPLICATION. IN CONCLUSION, THIS RCT SHOWED NO SIGNIFICANT DIFFERENCE IN HEALING WHEN CLOSED INCISION NPWT WAS APPLIED AFTER BCL SURGERY FOR COMPLICATED PSD. THE PERSISTENT ISSUE OF POOR WOUND HEALING IS A COMMON PROBLEM AMONG INDIVIDUALS WITH PSD THAT NECESSITATES ONGOING CLINICAL AND DEVELOPMENTAL ATTENTION. ON THE BASIS OF THE INTERIM ANALYSIS THE STUDY WAS DISCONTINUED AS A CLINICALLY RELEVANT IMPROVEMENT IN TREATMENT SEEMED UNLIKELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353968 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention