BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11234011 · Received January 26, 2021

    Report

    Report Number
    2210968-2021-00722
    Event Type
    Injury
    Date Received
    January 26, 2021
    Date of Event
    October 1, 2018
    Report Date
    January 4, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 4/28/2021. CORRECTED INFORMATION: B1, B2, D3, 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). 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 ETHICON PRODUCTS (BLAKE DRAIN, J-VAC RESERVOIR) INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS (INFLAMMATORY SEROMAS) (INFLAMMATION, SEROMA) DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS (BLAKE DRAIN, J-VAC RESERVOIR) USED IN THIS PROCEDURE? IF YES, PLEASE PROVIDE PATIENT DEMOGRAPHICS FOR THE PATIENTS THAT EXPERIENCED THE POST-OPERATIVE COMPLICATIONS (J-VAC/BLAKE: 61 YEARS OLD FEMALE PATIENT (SCMF GROUP) WHO DEVELOPED INFLAMAMTORY SEROMA). 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. NOTE: EVENTS REPORTED ON MW# 2210968-2021-00710, MW# 2210968-2021-00711, MW# 2210968-2021-00713, MW# 2210968-2021-00714, MW# 2210968-2021-00719, MW# 2210968-2021-00720, MW# 2210968-2021-00721. CITATION: ANN PLAST SURG 2018;81: 438¿440; DOI: 10.1097/SAP.0000000000001516.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE A DRAIN WAS USED: TITLE: POLYGLYCOLIC ACID FELT FOR PREVENTION OF FREY SYNDROME AFTER PAROTIDECTOMY AUTHOR(S): TETSUSHI AIZAWA, MD, MASAHIRO KUWABARA, MD, SATOSHI KUBO, MD, SHIMPO AOKI, MD, PHD, RYUICHI AZUMA, MD, PHD, AND TOMOHARU KIYOSAWA, MD, PHD CITATION: ANN PLAST SURG 2018;81: 438¿440; DOI: 10.1097/SAP.0000000000001516 THE PURPOSE OF THIS RETROSPECTIVE REVIEW WAS TO EVALUATE THE EFFECTIVENESS OF THIS POLYGLYCOLIC ACID (PGA) FELT AS A BARRIER FOR PREVENTING FREY SYNDROME. FROM 2012 TO 2017, 19 PATIENTS UNDERWENT SUPERFICIAL PAROTIDECTOMY. APPLICATION OF PGA FELT (N = 9) OR STERNOCLEIDOMASTOID FLAP (SCMF) TRANSFER (N = 10) WAS PERFORMED TO PREVENT FREY SYNDROME. IN BOTH GROUPS, A SUCTION DRAIN (J-VAC/BLAKE 15F; JOHNSON & JOHNSON K.K., TOKYO, JAPAN) WAS PLACED UNDER THE SKIN FLAP. NEITHER FREY SYNDROME NOR OTHER MAJOR COMPLICATIONS OCCURRED IN EITHER GROUP. TWO PATIENTS FROM EACH GROUP DEVELOPED AN INFLAMMATORY SEROMA THAT WAS SUCCESSFULLY TREATED WITH A SMALL INCISION FOR OPEN DRAINAGE WHOM INCLUDED 61 YEARS OLD FEMALE (PGA GROUP) PATIENT, 52 YEARS OLD MALE PATIENT (PGA GROU), 33 YEARS OLD MALE PATIENT (SCMF GROUP) AND 61 YEARS OLD FEMALE PATIENT (SCMF GROUP). IN PREVIOUS STUDIES OF ADM, PAPADOGEORGAKIS ET AL19 REPORTED THAT THE INCIDENCE OF SEROMA WAS 16%, AND SINHA ET AL21 REPORTED AN INCIDENCE OF 25%, WHICH WERE SIMILAR TO OUR RESULTS. USE OF PGA FELT SUCCESSFULLY PREVENTED FREY SYNDROME, WHILE BEING TECHNICALLY SIMPLER AND MORE RAPID COMPARED WITH SCMF TRANSFER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129186 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention