BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT

    MDR report key: 24327892 · Received February 12, 2026

    Report

    Report Number
    2210968-2026-01605
    Event Type
    Injury
    Date Received
    February 12, 2026
    Date of Event
    May 7, 2025
    Report Date
    February 12, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAN
    PMA / PMN Number
    K960653
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    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. 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. 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? 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: J PLAST RECONSTR AESTHET SURG. 2025 JUL;106:310-318. HTTPS://DOI.ORG/10.1016/J.BJPS.2025.04.041. EPUB 2025 MAY 7. PMID: 40460505.

    Description of Event or Problem · 0

    TITLE: OUTCOMES OF GENDER-AFFIRMING SIGMOID COLON VAGINOPLASTY: A RETROSPECTIVE STUDY OF 119 PATIENTS. THE AIM OF THIS STUDY IS TO ASSESS THE SAFETY AND EFFICACY OF SCV IN TGNB INDIVIDUALS AND COMPARE OUTCOMES BETWEEN PRIMARY SCV (N=66) AND REVISION SCV (N=53) CASES. THESE OUTCOMES WILL HELP INFORM SURGICAL DECISION-MAKING AND OPTIMIZE CARE FOR TGNB INDIVIDUALS SEEKING GENITAL GAS. 2-0 VICRYL (ETH) WAS USED TO ANCHORED TO A SEGMENT OF INVERTED PENILE SKIN AND THEN PASSED BACK INTO THE PELVIS TO ASSESS AND MAINTAIN APPROPRIATE TENSION PRIOR TO CLOSURE. WHILE 4-0 MONOCRYL (ETH) WAS USED TO SPLIT THE PENILE SKIN ALONG THE MIDLINE AND INSET AT THE BASE OF THE URETHRA AND ALONG THE LATERAL ASPECTS. LASTLY, 2-0 PDS (ETH) WERE USED TO ANCHORED THE SEROSAL AND MUSCULARIS LAYERS OF THE CONDUIT TO THE LEVATOR MUSCLES LATERALLY, MINIMIZING THE RISK OF PROLAPSE. REPORTED COMPLICATIONS: 2-0 VICRYL (ETH), 4-0 MONOCRYL (ETH), 2-0 PDS (ETH), PRIMARY SCV (N=66). SHORT TERM COMPLICATIONS: ADHESION FORMATION (N=1), TREATMENT: NOT REPORTED. BOWEL INJURY (N=1), TREATMENT: NOT REPORTED. DEHISCENCE (N=8), TREATMENT: NOT REPORTED. PARIETAL HEMATOMA (N=1), TREATMENT: NOT REPORTED. ILEUS (N=4), TREATMENT: NOT REPORTED. PROLAPSE (N=1), TREATMENT: NOT REPORTED. REOPERATION (N=2), TREATMENT: NOT REPORTED. LONG TERM COMPLICATIONS: DEHISCENCE (N=1), TREATMENT: NOT REPORTED. HYPER-GRANULATION TISSUE FORMATION (N=1), TREATMENT: NOT REPORTED. PROLAPSE (N=10), TREATMENT: NOT REPORTED. VAGINAL INTROITAL STENOSIS (N=6), TREATMENT: NOT REPORTED. REOPERATION (N=12), TREATMENT: NOT REPORTED. REVISION SCV (N=53), SHORT TERM COMPLICATIONS: BOWEL INJURY (N=3), TREATMENT: NOT REPORTED. DEHISCENCE (N=2), TREATMENT: NOT REPORTED. ILEUS (N=2), TREATMENT: NOT REPORTED. VAGINAL BLEEDING (N=2), TREATMENT: NOT REPORTED. FULL-THICKNESS FLAP LOSS / INTESTINAL CONDUIT FAILED (N=1), TREATMENT: NOT REPORTED. REOPERATION (N=4), TREATMENT: NOT REPORTED. LONG TERM COMPLICATIONS: PROLAPSE (N=4), TREATMENT: NOT REPORTED. VAGINAL INTROITAL STENOSIS (N=5), TREATMENT: NOT REPORTED. REOPERATION (N=8), TREATMENT: NOT REPORTED. IN CONCLUSIONS, SCV IS A SAFE AND EFFECTIVE ALTERNATIVE TO PIV, WITH COMPARABLE COMPLICATION AND REOPERATION RATES. ALTHOUGH MUCOSAL PROLAPSE REMAINS A CONCERN, SCV MAY BE PREFERABLE FOR PATIENTS WITH PENOSCROTAL HYPOPLASIA, HIGHER BMI, OR COMPLETE VAGINAL STENOSIS. FURTHERMORE, PATIENT PREFERENCES AND TISSUE AVAILABILITY SHOULD GUIDE SURGICAL DECISIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383240 MONOCRYL POLIGLECAPRONE 25 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAN ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention