BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11600070 · Received March 31, 2021

    Report

    Report Number
    2210968-2021-02930
    Event Type
    Injury
    Date Received
    March 31, 2021
    Date of Event
    January 29, 2021
    Report Date
    March 7, 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: 4/12/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THERE IS AN ALLEGED DEFICIENCY OF THE BLAKE DRAIN THAT MAY HAVE CONTRIBUTED TO THE EVENT? IF SO, CAN DETAILS BE PROVIDED? NO FURTHER INFORMATION IS AVAILABLE. WERE THERE ANY ANOMALIES WITH THE DRAIN: APPEARANCE, DAMAGE OR FUNCTION? NO FURTHER INFORMATION IS AVAILABLE. HOW WAS THE BLAKE DRAIN SECURED? NO FURTHER INFORMATION IS AVAILABLE. WAS THE DRAIN CHECKED FOR PATENCY DURING THE PROCEDURE? NO FURTHER INFORMATION IS AVAILABLE. DID THE DRAIN FUNCTION AS INTENDED? NO FURTHER INFORMATION IS AVAILABLE. WERE ANY ISSUES NOTED WITH THE DRAIN DURING USE? NO FURTHER INFORMATION IS AVAILABLE. WHAT IS THE SURGEON¿S OPINION OF THE IMPACT OF THE DRAIN ON THE PATIENT CONSEQUENCES? NO FURTHER INFORMATION IS AVAILABLE. NO FURTHER INFORMATION WILL BE PROVIDED. 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). DATE SENT TO THE FDA: 7/6/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE PATIENT'S NERVE PARALYSIS HAS RECOVERED AND IS NOW ABLE TO SPEAK. 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). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: THE PATIENT IS (B)(6) YEARS OLD WOMAN. THE FINAL PATHOLOGY WAS ADENOMATOUS THYROID. ON (B)(6) 2021, RIGHT LOBECTOMY OF THYROID GLAND WAS PERFORMED FOR THYROID TUMOR. AFTER NERVE SPARING WAS CONFIRMED BY INTRAOPERATIVE NIM, THE SURGICEL POWDER WAS SPRAYED. (NO WASHING AFTER SPRAYING.) A 15 FR J-VAC DRAIN WAS PLACED IN THE RIGHT PARATRACHEAL REGION NEAR THE TRACHEA. ON (B)(6) THE PATIENT STARTED TO DRINK WATER. THERE WAS NO EPISODE OF HOARSENESS OR ASPIRATION. ON (B)(6) THE DRAIN WAS REMOVED. EXCESSIVE LEAKAGE OF DRAINAGE FLUID FROM THE WOUND. (JANUARY 29, THERE IS NO MOVEMENT OF THE RIGHT VOCAL CORD IN THE DYNAMIC IMAGES CURRENTLY UNDER WAY AT THE HOSPITAL.) ON (B)(6) THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) HOARSENESS WAS NOTED AT THE INITIAL OUTPATIENT VISIT. SINCE THERE WAS OOZING AROUND THE NERVE, PHYSICIAN USED SURGICEL POWDER ON THE NERVE PART, BUT PHYSICIAN WAS AFRAID THAT IT SEEMED THE AMOUNT OF POWDER WAS TOO MUCH. THE WOUND WAS ACTUALLY CLOSED WITHOUT BEING WASHED AWAY, WHICH MAY HAVE AFFECTED THE WOUND. THE SURGEON DID NOT USE ALL OF THE SURGICEL POWDER BECAUSE OF ITS LARGE VOLUME, BUT USED ABOUT 2 G. WHAT IS THE PROCEDURE DATE? (B)(6) 2021. WHAT DATE DID THE LARYNGEAL NERVE PARALYSIS OCCUR ON? (B)(6). WHAT IS THE SURGEON¿S OPINION AS TO THE RELATIONSHIP OF THE PRODUCT TO THE SYMPTOMS? PHYSICIAN COMMENTED THAT THERE ARE VARIOUS FACTORS AS THE CAUSE OF RECURRENT LARYNGEAL NERVE PALSY, SO HE COULD NOT DETERMINE POWDER CAUSED THIS ISSUE BUT HE THOUGHT POWDER HAD SOME INFLUENCE SINCE THIS CASES WERE DONE A NERVE STIMULATOR EXAMINATION AND FOUND NO NERVE PALSY AFTER THE PROCEDURE. THE SURGEON THOUGHT THAT IF THE SURGICEL POWDER HEATS WHEN IT ABSORBS BLOOD AND CONGEALS, OR IF IT ABSORBS TOO MUCH WATER (NEURAL), THE OSMOTIC PRESSURE MAY DAMAGE THE NERVE. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED TO TREAT THE LARYNGEAL NERVE PARALYSIS (RE-OPERATION; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. THE PATIENT GOES TO A HOSPITAL REGULARLY. WHAT IS THE MOST CURRENT PATIENT STATUS? NOT IMPROVED. CAN YOU IDENTIFY THE LOT NUMBER OF THE PRODUCT THAT WAS USED? NO FURTHER INFORMATION IS AVAILABLE. CAN YOU PLEASE CLARIFY THE TOTAL NUMBER OF PROCEDURES? 1 CASE. IF THIS EVENT OCCURRED IN MULTIPLE PROCEDURES, BUT HAVEN'T BEEN REPORTED TO ETHICON, PLEASE OPEN 1 ADDITIONAL FOR EACH ADDITIONAL PATIENT PROCEDURE. OK. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL WITH RECURRENT LARYNGEAL NERVE PARALYSIS REMAINING. RECURRENT LARYNGEAL NERVE PALSY WAS FOUND THE DAY AFTER UNILATERAL THYROIDECTOMY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WILL VISIT THE HOSPITAL IN THE FUTURE REGULARLY. THE PATIENT WILL VISIT THE HOSPITAL AND SEE HOW IT GOES. THE PATIENT MAY BE ABLE TO MOVE IN 2 ~ 3 MONTHS. IF THE PATIENT DOES NOT MOVE, SURGERY FOR VOICE IMPROVEMENT MAY BE PERFORMED. THERE WAS CAUSAL RELATIONSHIP BETWEEN THE PRODUCT AND EVENT. 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 THERE IS AN ALLEGED DEFICIENCY OF THE BLAKE DRAIN THAT MAY HAVE CONTRIBUTED TO THE EVENT? IF SO, CAN DETAILS BE PROVIDED? IT WAS NOTED AN UNKNOWN BLAKE DRAIN WAS PLACED ON (B)(6) AND REMOVED (B)(6). WERE THERE ANY ANOMALIES WITH THE DRAIN: APPEARANCE, DAMAGE OR FUNCTION? HOW WAS THE BLAKE DRAIN SECURED? WAS THE DRAIN CHECKED FOR PATENCY DURING THE PROCEDURE? DID THE DRAIN FUNCTION AS INTENDED? WERE ANY ISSUES NOTED WITH THE DRAIN DURING USE? WHAT IS THE SURGEON¿S OPINION OF THE IMPACT OF THE DRAIN ON THE PATIENT CONSEQUENCES? NOTE: EVENTS REPORTED ON MW# 2210968-2021-02452. 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN THYROIDECTOMY PROCEDURE ON (B)(6) 2021 AND A DRAIN WAS USED. AFTER THE PROCEDURE, RECURRENT LARYNGEAL NERVE PARALYSIS OCCURRED. NO PRODUCT TO BE RETURNED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496793 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention