BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 22127112 · Received June 2, 2025

    Report

    Report Number
    2210968-2025-06130
    Event Type
    Injury
    Date Received
    June 2, 2025
    Date of Event
    January 1, 2024
    Report Date
    June 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. 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: DIS COLON RECTUM. 2024 AUG 1;67(8):1065-1071. HTTPS://DOI.ORG/10.1097/DCR.0000000000003312. EPUB 2024 MAY 3. PMID: 38701430; PMCID: PMC11250094.

    Description of Event or Problem · 0

    TITLE: ADDITION OF PLATELET-RICH PLASMA TO ENDORECTAL ADVANCEMENT FLAP REPAIR DOES NOT ENHANCE THE HEALING OF CRYPTOGLANDULAR TRANSSPHINCTERIC FISTULAS. THIS RETROSPECTIVE COHORT STUDY AIMED TO COMPARE SHORT-TERM AND LONG-TERM HEALING RATES AFTER ENDORECTAL ADVANCEMENT FLAP REPAIR WITH AND WITHOUT PLATELET-RICH PLASMA (PRP) INJECTION IN A PROPENSITY SCORE¿WEIGHTED COHORT STUDY THAT INCLUDED PATIENTS WITH A CRYPTOGLANDULAR TRANSSPHINCTERIC FISTULA. BETWEEN NOVEMBER 2005 AND AUGUST 2019, A TOTAL OF 219 (MALE=154; MEAN AGE=46.3 YEARS) PATIENTS WITH A CRYPTOGLANDULAR TRANSSPHINCTERIC FISTULA UNDERWENT ENDORECTAL ADVANCEMENT FLAP REPAIR WHILE USING 3.0 OR 4.0 VICRYL SUTURE AND 2/0 MONOCRYL (ETHICON INC, SOMERVILLE, NJ). A TOTAL OF (N=88) PATIENTS WERE TREATED WITH PRP, AND A TOTAL OF (N=131) WERE TREATED WITHOUT PRP. REPORTED COMPLICATIONS ARE: 3.0 OR 4.0 VICRYL SUTURE, 2/0 MONOCRYL, BLEEDING (N = 9), TREATMENT: TREATED WITH A CONSERVATIVE APPROACH, POSTOPERATIVE ABSCESS (N = 7), TREATMENT: TREATED WITH INCISION AND DRAINAGE, FLAP DEHISCENCE (N = 1), TREATMENT: ADDITIONAL FLAP REPAIR, HEALING FAILURE (N=39), TREATMENT: REINTERVENTION, WITHOUT HEALING WITHIN 1 YEAR AFTER SURGERY (N=31), TREATMENT: DID NOT UNDERGO REINTERVENTION, RECURRENCE (N=5), TREATMENT: NOT REPORTED. IN CONCLUSION, INJECTION OF PRP AS AN ADD-ON TO ENDORECTAL ADVANCEMENT FLAP REPAIR DOES NOT IMPROVE THE SHORT-TERM AND LONG-TERM OUTCOME OF ENDORECTAL ADVANCEMENT FLAP REPAIR IN PATIENTS WITH A CRYPTOGLANDULAR TRANSSPHINCTERIC FISTULA TREATED IN A TERTIARY REFERRAL CENTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1493190 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention