BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 23406351 · Received October 28, 2025

    Report

    Report Number
    2210968-2025-12251
    Event Type
    Injury
    Date Received
    October 28, 2025
    Date of Event
    October 17, 2024
    Report Date
    October 28, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. CITATION: ASIAN J ENDOSC SURG. 2024 OCT;17(4):E13384. HTTPS://DOI.ORG/10.1111/ASES.13384 PMID: 39252203.

    Description of Event or Problem · 0

    TITLE: ENDOSCOPIC LAVAGE FOR AN INFECTED PELVIC HEMATOMA IN A PATIENT WITH PELVIC SEPSIS AFTER ANTERIOR PELVIC EXENTERATION. THE AIM OF THIS STUDY IS TO PRESENT A CASE OF A 47-YEAR-OLD MAN TREATED FOR A SEVERELY INFECTED PELVIC HEMATOMA AND SEPSIS FOLLOWING ANASTOMOTIC LEAKAGE AFTER ANTERIOR PELVIC EXENTERATION. 19-FR J-VAC DRAIN (ETH) WAS PLACED FROM THE RIGHT LOWER ABDOMEN TO THE PELVIC CAVITY, UNDER THE DIAPHRAGM ON THE LEFT AND RIGHT AND INTO THE RECTOVESICAL FOSSA, AND WAS ADDED TRANSANALLY TO THE PELVIC CAVITY FOR IMPROVED LAVAGE AND DRAINAGE. REPORTED COMPLICATIONS: 19-FR J-VAC DRAIN (ETH) BLEEDING LEFT INTERNAL ILIAC PSEUDOANEURYSM. TREATMENT: EMBOLIZATION FEVER TREATMENT: NOT REPORTED ABDOMINAL PAIN TREATMENT: EMERGENCY LAPAROSCOPIC SURGERY UNDER GENERAL ANESTHESIA DARK RED ABDOMINAL CAVITY WITH CLOTS TREATMENT: NOT REPORTED INFLAMMATORY, THICKENED, SCLEROTIC ANASTOMOTIC COLON TREATMENT: NOT REPORTED PSEUDOANEURYSM TREATMENT: NOT REPORTED PELVIC BLEEDING TREATMENT: NOT REPORTED SEPSIS TREATMENT: NOT REPORTED GRADUAL ABSCESS FORMATION TREATMENT: NOT REPORTED INFECTION TREATMENT: NOT REPORTED ANASTOMOTIC DEHISCENCE TREATMENT: NOT REPORTED HEMATOMA TREATMENT: COLONOSCOPY. IN CONCLUSION, ENDOSCOPIC LAVAGE WAS CONSIDERED HIGHLY BENEFICIAL DUE TO ITS MINIMALLY INVASIVE NATURE, EFFECTIVE CONTROL OF PELVIC SEPSIS CAUSED BY AN INFECTED HEMATOMA, AVOIDANCE OF INVASIVE PELVIC SURGERY, AND ULTIMATELY ENABLING PRESERVATION OF THE ANUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744922 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Required Intervention