BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 23038641 · Received September 12, 2025

    Report

    Report Number
    2210968-2025-10430
    Event Type
    Injury
    Date Received
    September 12, 2025
    Date of Event
    February 25, 2025
    Report Date
    September 12, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: FOOT & ANKLE SURGERY: TECHNIQUES, REPORTS & CASES 5 (2025) 100480. DOI: HTTPS://DOI.ORG/10.1016/J.FASTRC.2025.100480.

    Description of Event or Problem · 0

    TITLE: STINGRAY ENVENOMATION IN THE FOOT & ITS EFFECTS ON WOUND HEALING: A CASE REPORT. THE AIM OF THIS STUDY IS TO PRESENT A CASE OF A 60-YEAR-OLD HEALTHY MALE AFTER A DAY OF FISHING IN THE SHALLOW WATERS OF LONG ISLAND, NEW YORK. HIS CHIEF COMPLAINT WAS A RED, HOT, SWOLLEN AND PAINFUL FOOT SECONDARY TO A STINGRAY INJURY THAT OCCURRED WHILE FISHING. PROLENE 3-0 (ETH) SUTURE WAS USED TO CLOSED THE WOUND. REPORTED COMPLICATION: PROLENE 3-0 (ETH). DEHISCENCE TREATMENT: NOT REPORTED. IN CONCLUSION, STINGRAY INJURIES TO THE LOWER EXTREMITY ARE NOT ATYPICAL. STINGRAY INJURIES TO THE FOOT CAN BE COMPLICATED BY INFECTION, TISSUE NECROSIS, DELAYED WOUND HEALING, AND SECONDARY BACTERIAL INFECTION IT IS IMPORTANT TO MAINTAIN CLOSE FOLLOW-UP CARE WITH THESE PATIENTS AFTER INITIAL TREATMENT IN THE HOSPITAL TO MONITOR FOR WOUND HEALING COMPLICATIONS. `

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1975039 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Other