BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11276832 · Received February 3, 2021

    Report

    Report Number
    2210968-2021-01057
    Event Type
    Injury
    Date Received
    February 3, 2021
    Date of Event
    June 7, 2020
    Report Date
    January 15, 2021
    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). DATE SENT TO THE FDA: 4/13/2021. CORRECTED INFORMATION: B1, B2, H1, H6- ADDITIONAL INFORMATION WAS RECEIVED THAT THERE ARE NO ISSUES WITH THIS DEVICE IN THE PATIENT EVENT. THEREFORE, THIS MEDWATCH REPORT WILL BE VOIDED. 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 · 1

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED HOWEVER NOT RECEIVED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS (BLAKE DRAIN) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (ITCHING, PAIN, SCAR) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (BLAKE DRAIN) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (ITCHING, PAIN, SCAR). WERE THESE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. 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. THE SINGLE COMPLAINT WAS REPORTED WITH MULTIPLE EVENTS. THERE ARE NO ADDITIONAL DETAILS REGARDING THE ADDITIONAL EVENTS. CITATION: SURGERY TODAY (2020) 50:1626¿1632. DOI: HTTPS://DOI.ORG/10.1007/S00595-020-02043-1 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 · 1

    TITLE: WHERE DO YOU INSERT A DRAIN TUBE DURING BREAST RECONSTRUCTION? AUTHORS: HIROSHI NISHIOKA · YOSHICHIKA YASUNAGA · DAISUKE YANAGISAWA · SHUNSUKE YUZURIHA · KEN-ICHI ITO. CITATION: SURGERY TODAY (2020) 50:1626¿1632. DOI: HTTPS://DOI.ORG/10.1007/S00595-020-02043-1. THIS STUDY WAS PERFORMED TO INVESTIGATE HOW PATIENTS FEEL ABOUT THE DRAIN SCAR AFTER BREAST RECONSTRUCTION SURGERY, IF THERE ARE ANY DIFFERENCES IN DRAIN SCARS ACCORDING TO THE LOCATION OF THE DRAIN, THE IDEAL DRAIN SCAR LOCATION ACCORDING TO BOTH PATIENTS AND FEMALE MEDICAL STAFF AND WHETHER THERE ARE ANY INTERGENERATIONAL DIFFERENCES REGARDING THE IDEAL LOCATION OF THE DRAIN SCAR. A TOTAL OF 38 CONSECUTIVE PATIENTS (AGE 25¿70) WHO CAME BETWEEN NOVEMBER 2017 AND FEBRUARY 2018 FOR REGULAR OUTPATIENT TREATMENT MORE THAN 6 MONTHS AFTER RECEIVING BREAST RECONSTRUCTION SURGERY. DURING THE PROCEDURE, ONE OR TWO 15FR SILICON DRAIN TUBE (BLAKE® SILICONE DRAIN TUBE; ETHICON SOMERVILLE, NJ, USA) WERE USED AND WERE FIXED TO THE SKIN. REPORTED COMPLICATIONS INCLUDED 5 PATIENTS HAD A SCAR AT THE AXILLA (AGE: 25¿64 YEARS, RECONSTRUCTION METHOD: TISSUE EXPANDER/BREAST IMPLANT (TE/ IMP), 3; LATISSIMUS DORSI (LD) FLAP, 1; FREE DEEP INFERIOR EPIGASTRIC ARTERY PERFORATOR (DIEP) FLAP, 1), 18 PATIENTS HAD A SCAR AT THE SIDE OF THE CHEST (AGE: 29¿70 YEARS, RECONSTRUCTION METHOD: TE/IMP, 16; DIEP, 2), 15 PATIENTS HAD A SCAR AT THE SIDE OF THE ABDOMEN (AGE: 36¿68 YEARS, RECONSTRUCTION METHOD: TE/IMP, 8; LD, 3; DIEP, 4), ANXIOUS ABOUT THE DRAIN SCAR ¿ALL OF THE TIME¿ (N-1), ANXIOUS ABOUT THE DRAIN SCAR ¿SOME OF THE TIME¿ (N-11), ANXIOUS ABOUT THE DRAIN SCAR ¿HARDLY EVER¿ (N-14), CHIEF COMPLAINTS ABOUT THE DRAIN SCAR WERE ¿APPEARANCE¿ (N-22), CHIEF COMPLAINTS ABOUT THE DRAIN SCAR WERE ¿ITCHING¿ (N-2), CHIEF COMPLAINTS ABOUT THE DRAIN SCAR WERE ¿PAIN¿ (N-2), HAS A SCORE IN JAPAN SCAR WORKSHOP (JSW) SCAR SCALE SCORE (N-?), SLIGHT HYPERPIGMENTATION (N-1), HYPERPIGMENTATION STOOD OUT (N-1) IN WHICH THE PATIENT DID NOT REQUEST ANY TREATMENT, SCAR WAS ELEVATED WITH HYPERGIMENTATION ACCOMPANIED WITH PAIN (N-1). MOST OF THE COMPLAINTS ABOUT THE DRAIN SCARS IN OUR COHORT IMPROVED AFTER THE ADMINISTRATION OF INTRALESIONAL CORTICOSTEROID INJECTION, OINTMENTS, TAPES AND PLASTERS. THERE IS NO GENERAL AGREEMENT OVER THE IDEAL DRAIN SCAR LOCATION, SO THE SURGEON SHOULD CONSIDER THE PATIENT¿S AGE, THEIR REGULAR MODE OF DRESS AND FROM THE PRESENT TO THE FUTURE LIFESTYLE TO DECIDE ON THE DRAIN LOCATION WITH THE PATIENT BEFORE THE OPERATION. THEREFORE, MORE PATIENT INVOLVEMENT OR INFORMATION WITH RESPECT TO DRAIN PLACEMENT IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    167854 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention