BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 19829569 · Received July 25, 2024

    Report

    Report Number
    2210968-2024-07655
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    June 18, 2021
    Report Date
    August 20, 2024
    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
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT (B)(4). ADDITIONAL INFORMATION: H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED ADDITIONAL INFORMATION HAS BEEN REQUESTED HOWEVER NOT RECEIVED. ATTEMPTS TO OBTAIN THE DEVICE HAVE BEEN MADE. 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: BLAKE DRAIN UNKNOWN, INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS: - SEVERE PLEURAL ADHESIONS TREATMENT: CONVERSION TO A TRIPORTAL APPROACH, DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED: BLAKE DRAIN UNKNOWN, 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? THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. NO PRODUCT AVAILABLE FOR RETURN. CITATION: HTTPS://DOI.ORG/10.1007/S11748-021-01647-9 AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION HAS BEEN REQUESTED AND RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. NO FURTHER INFORMATION WILL BE PROVIDED BECAUSE WE CAN¿T GET ANY ADDITIONAL INFORMATION FROM THE AUTHOR. 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, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON, 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.

    Description of Event or Problem · 0

    TITLE: A PROSPECTIVE COMPARATIVE STUDY OF THORACOSCOPIC TRANSAREOLAR AND UNIPORTAL APPROACHES FOR YOUNG MALE PATIENTS WITH PRIMARY SPONTANEOUS PNEUMOTHORAX IN THIS STUDY, WE INTRODUCE A NOVEL APPROACH, THORACOSCOPIC TRANSAREOLAR BULLECTOMY, FOR TREATING YOUNG MALE PATIENTS WITH PRIMARY SPONTANEOUS PNEUMOTHORAX (PSP). THIS APPROACH MIGHT BE LESS INVASIVE AND COSMETICALLY SUPERIOR TO EXISTING METHODS. WE ALSO PROSPECTIVELY COMPARED TRANSAREOLAR AND UNIPORTAL APPROACHES. BETWEEN APRIL 2018 AND JULY 2019, 40 PATIENTS WERE PROSPECTIVELY ASSIGNED TO TRANSAREOLAR (N=21) AND UNIPORTAL (N=19) GROUPS. AFTER CONFIRMATION OF THE PRESENCE OF BLEBS OR BULLAE, WE EXCISED THEM USING AN ENDOSTAPLER (POWERED ECHELON FLEX GST SYSTEM; JOHNSON & JOHNSON). WE THEN APPLIED POLYGLYCOLIC ACID FELT (NEOVEIL, SHEET TYPE; IGAKI MEDICAL PLANNING CO., LTD., KYOTO, JAPAN) TO THE STAPLE LINES USING FIBRIN GLUE (BERIPLAST P; CSL BEHRING, KING OF PRUSSIA, PA, USA); THIS PREVENTED ANY POSTOPERATIVE AIR LEAKAGE AND REDUCED THE RECURRENCE RATE. FINALLY, A 19-FRENCH DRAIN (BLAKE DRAIN; ETHICON, PARAMUS, NJ, USA) WAS POSITIONED IN THE ANTERIOR-TO-POSTERIOR DIRECTION THROUGH THE PATIENT ENROLMENT APEX IN AN INVERTED U SHAPE THE REPORTED COMPLICATION INCLUDED (N=1) SEVERE PLEURAL ADHESIONS TREATMENT: CONVERSION TO A TRIPORTAL APPROACH. IN CONCLUSION, ALTHOUGH THE PERIOPERATIVE RESULTS OF THE TRANSAREOLAR AND UNIPORTAL APPROACHES WERE SIMILAR, THE FORMER APPROACH AFFORDED A LITTLE BETTER COSMETIC SATISFACTION AND MIGHT BE USEFUL OPTION FOR YOUNG MALES WITH PSP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244599 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention