BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22470641 · Received July 10, 2025

    Report

    Report Number
    2210968-2025-08029
    Event Type
    Injury
    Date Received
    July 10, 2025
    Date of Event
    July 15, 2024
    Report Date
    July 10, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. 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: THER ADV UROL. 2024 SEP 26;16:17562872241280021. HTTPS://DOI.ORG/10.1177/17562872241280021 PMID: 39372547; PMCID: PMC11456194.

    Description of Event or Problem · 0

    TITLE: OUTCOMES AND PATIENT SATISFACTION AFTER PENUMA SILICONE IMPLANT SURGERY VIA TWO SURGICAL APPROACHES. THE AIM OF THIS STUDY IS TO REPORT OUTCOMES ON PATIENT SATISFACTION AT LEAST 6MONTHS AFTER PENUMA SUBCUTANEOUS PENILE IMPLANT FOR COSMETIC ENHANCEMENT OF THE PENIS, AND TO DETERMINE IF MODIFICATIONS IN SURGICAL APPROACH RESULTED IN REDUCTION IN POSTOPERATIVE COMPLICATIONS. ALL 92 PATIENTS WHO UNDERWENT A PENUMA IMPLANT BY A SINGLE SURGEON FROM APRIL 2019 TO DECEMBER 2022. A 26-ITEM NONVALIDATED DEVICE-SPECIFIC QUESTIONNAIRE WAS SENT TO PATIENTS AT LEAST 6MONTHS AFTER THE DATE OF THEIR INITIAL SURGERY. ETHIBOND (2-0,3-0; ETH) WHICH WERE USED TO BROUGHT ON THE FIELD AND SECURED TO THE SUBCORONAL SULCUS TUNICA ALBUGINE AND SECURED THE DEVICE. REPORTED COMPLICATIONS: ETHIBOND (2-0,3-0; ETH) SEROMA (N=11) TREATMENT: REQUIRING DRAINAGE UNDER LOCAL ANESTHESIA IMPLANT MALPOSITION (N=6) TREATMENT: OPERATIVE REVISION DISTAL FLARING OF THE DEVICE (N=3) TREATMENT: OPERATIVE REVISION PROMIXAL DISLODGMENT (N=2) TREATMENT: OPERATIVE REIVION EROSION (N=4) TREATMENT: DEVICE REMOVED DISTAL SHAFT SKIN PERFORATION (N=2) TREATMENT: DEVICES SUCCESSFULLY PLACED AT A SEPARATE ENCOUNTER IN CONCLUSION, THE SUBCUTANEOUS PENUMA PENILE IMPLANT APPEARS TO IMPROVE SATISFACTION WITH REGARD TO THE APPEARANCE OF THE PENIS AND IS A VIABLE OPTION FOR MEN WHO DESIRE TO ENHANCE FLACCID PENILE LENGTH AND GIRTH. FURTHERMORE, THE LATERAL SCROTAL SURGICAL APPROACH APPEARS TO HAVE A LOWER POSTOPERATIVE COMPLICATION RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1678211 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention