BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22513372 · Received July 15, 2025

    Report

    Report Number
    2210968-2025-08162
    Event Type
    Injury
    Date Received
    July 15, 2025
    Date of Event
    March 5, 2024
    Report Date
    July 15, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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: INT J IMPOT RES. 2025 JAN;37(1):72-75. HTTPS://DOI.ORG/10.1038/S41443-024-00843-4 EPUB 2024 MAR 5. PMID: 38443553.

    Description of Event or Problem · 0

    TITLE: GLANS HYPERMOBILITY SCALE (GHS): A SIMPLE GRADING SCALE AND DESCRIPTION OF A MODIFIED GLANSPEXY TECHNIQUE. THE AIM OF THIS STUDY IS TO DEVELOP A NOVEL GRADING SCALE TO ASSESS GH SEVERITY INTRAOPERATIVELY DURING PRIMARY INFLATABLE PENILE PROSTHESIS (IPP) PLACEMENT AND DESCRIBE A MODIFIED GLANSPEXY TECHNIQUE TO CORRECT GH WHEN ENCOUNTERED DURING IPP PLACEMENT. 530 PATIENTS WHO UNDERWENT PRIMARY IPP PLACEMENTS FROM TWO HIGH-VOLUME PROSTHETIC SURGEONS BETWEEN (B)(6) 2018 ¿ (B)(6) 2019 WERE RETROSPECTIVELY REVIEWED IN ORDER TO IDENTIFY THE INCIDENCE OF GH. OF THESE, 139 (26.2%) HAD HYPERMOBILITY. ETHIBOND (ETH) WAS USED TO PASSED THROUGH BUCKS FASCIA, WITH CARE TAKEN TO AVOID INJURY TO THE UNDERLYING PROSTHESIS CYLINDER, THEN PASSED FROM THE INCISION DEEP TO THE DARTO¿S TISSUE AND INTO THE ¿MEATY¿ PORTION OF THE IPSILATERAL GLANS PENIS AND SUBSEQUENTLY TIED DOWN AT THE LEVEL OF THE INCISION WITH THE APPROPRIATE TENSION TO COVER THE DISTAL CYLINDER TIP AND RESOLVE THE GLANS HYPERMOBILITY. ADDITIONALLY, 2-0 ETHIBOND WAS USED IN ANCHORING SUTURES, WAS TAKEN AT THE LEVEL OF THE TIP OF THE UNINFLATED CYLINDER. LASTLY, 2-0 ETHIBOND, WAS PLACED ON THE SIDE OPPOSITE THE GLANS DEVIATION THROUGH A SEPARATE INCISION. REPORTED COMPLICATIONS: 2-0 ETHIBOND (ETH), SUTURE GRANULOMA (N=1), TREATMENT: PARTIAL DEVICE EXPLANT, PAIN (N=1), TREATMENT: REPEAT CORRECTION. IN CONCLUSION, GLANS HYPERMOBILITY AFTER IPP PLACEMENT MAY BE AN UNDER APPRECIATED CLINICAL ENTITY. THE NOVEL GHS INTRODUCED HEREIN PROVIDES A PLATFORM FOR SURGEONS TO ROUTINELY DOCUMENT HYPERMOBILITY. FUTURE RESEARCH SHOULD FOCUS ON SEVERAL AREAS INCLUDING IDENTIFYING RISK FACTORS FOR GH AND CORRELATING OBJECTIVE GH SEVERITY WITH SUBJECTIVE PATIENT BOTHER OR THE NEED FOR INTRAOPERATIVE GH CORRECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154094 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention