BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT

    MDR report key: 24313714 · Received February 11, 2026

    Report

    Report Number
    2210968-2026-01500
    Event Type
    Injury
    Date Received
    February 11, 2026
    Date of Event
    October 10, 2025
    Report Date
    February 11, 2026
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    PMA / PMN Number
    K022269
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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: IBRAHIM ET AL. AFRICAN JOURNAL OF UROLOGY (2025) 31:55; HTTPS://DOI.ORG/10.1186/S12301-025-00521-X.

    Description of Event or Problem · 0

    TITLE: CAN A PLATELET-RICH PLASMA COVERING LAYER REDUCE URETHROCUTANEOUS FISTULA RATE AFTER DISTAL PENILE HYPOSPADIAS REPAIR USING THE STAR (SELEIM¿S TOPOGRAPHY-GUIDED ANATOMICAL REASSEMBLY) TECHNIQUE? A RANDOMIZED CONTROLLED TRIAL. THE AIM OF THIS STUDY IS TO EVALUATE THE BENEFIT OF USING PLATELET-RICH PLASMA (PRP) COVERING LAYER IN DECREASING URETHROCUTANEOUS FISTULA RATE POST-DISTAL PENILE HYPOSPADIAS REPAIR USING THE STAR TECHNIQUE. THIS PROSPECTIVE RANDOMIZED CONTROLLED TRIAL INCLUDED 44 BOYS WITH PRIMARY DISTAL PENILE HYPOSPADIAS. PATIENTS WERE RANDOMIZED INTO TWO GROUPS: GROUP A (N=22) UNDERWENT REPAIR USING THE STAR TECHNIQUE WITH AN ADDITIONAL PRP LAYER OVER THE NEOURETHRA, WHILE GROUP B (N=22) RECEIVED THE STAR REPAIR WITHOUT PRP. PRP WAS PREPARED FROM AUTOLOGOUS BLOOD AND APPLIED AS AN INTERMEDIATE LAYER BEFORE SKIN CLOSURE. AN INTERRUPTED SINGLE-LAYERED SPONGIOPLASTY (ZIPPER CLOSURE) USING 6/0 VICRYL ABSORBABLE SUTURES (13 MM NEEDLE, ETHICON INC, SOMERVILLE, NEW JERSEY) IS APPLIED OVER A NELATON CATHETER. LASTLY, THE GLANSPLASTY IS DONE USING 3 SLANTING SUTURES. PATIENTS WERE FOLLOWED FOR AT LEAST 4 WEEKS. REPORTED COMPLICATIONS: 6/0 VICRYL ABSORBABLE SUTURES (ETHICON): (N=1) PATIENT HAD PENILE EDEMA. TREATMENT: RESOLVED WITH CONSERVATIVE MANAGEMENT BY THE SECOND WEEK. (N=1) PATIENT HAD MEATAL STENOSIS. TREATMENT: PATIENT RESPONDED TO DILATATION AND DID NOT REQUIRE SURGICAL MEATOTOMY. (N=7) HAD URETHROCUTANEOUS FISTULA. TREATMENT: IT WAS MANAGED SUCCESSFULLY WITH U.C. FISTULA CLOSURE AT THE 6TH MONTH. IN CONCLUSION, THIS RANDOMIZED CONTROLLED TRIAL PROVIDES EVIDENCE THAT UTILIZING A PLATELET-RICH PLASMA (PRP) COVERING LAYER DURING DISTAL HYPOSPADIAS REPAIR (STAR TECHNIQUE) CAN SIGNIFICANTLY REDUCE THE INCIDENCE OF POSTOPERATIVE URETHROCUTANEOUS FISTULA, WHILE PRP DID NOT MARKEDLY INFLUENCE OTHER OUTCOMES SUCH AS EDEMA, MEATAL STENOSIS, OR OPERATIVE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    380087 VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention