BEUDAMED
    FDA Adverse Event Death Summary report: N

    VCL+ UD 27IN 5-0 S/A TF

    MDR report key: 12558215 · Received September 30, 2021

    Report

    Report Number
    2210968-2021-09052
    Event Type
    Death
    Date Received
    September 30, 2021
    Date of Event
    August 22, 2021
    Report Date
    October 22, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GAM
    UDI-DI
    10705031053199
    PMA / PMN Number
    K032420
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE SENT TO THE FDA: 10/22/2021. ATTEMPTS ARE BEING MADE TO CLARIFY 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. 1. IS THERE ANY ALLEGED DEFICIENCY OF SUTURES (VCP433H AND W8710) WHICH WERE USED FOR RE-SUTURING AT (B)(6) 2021 RE-OPERATION RELATED TO THE PATIENT'S DEATH? IF YES, PLEASE EXPLAIN. 2. DATE OF PATIENT'S DEATH? ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WAS A CAUSE OF DEATH REPORTED WITHIN THE MEDICAL RECORD OR DESCRIBED IN AN AUTOPSY REPORT? IF SO, PLEASE SPECIFY. - THE PHYSICIAN CONSIDERED THAT THE PATIENT¿ S RAISED INCISION AFTER THE PROCEDURE WAS DUE TO THE "TOO FAST" ABSORPTION OF THE SUTURE RESULTING IN DEHISCENCE OF THE DURAL SUTURE AND CEREBROSPINAL FLUID OVERFLOW. DURING THE INVESTIGATION, IT WAS LEARNED THAT THE PATIENT DIED DUE TO INTRACRANIAL HEMORRHAGE, AND THE PHYSICIAN DID NOT PROVIDE ANY RELEVANT INFORMATION OR WOUND CONDITION. DATE OF PATIENT¿S DEATH? - UNKNOWN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803, PART 4 SUBPART B. 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

    (B)(4). THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. (B)(4). TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. THE ACTUAL DEVICE BATCH NUMBER ASSOCIATED WITH THIS EVENT IS NOT KNOWN. THE INTERNATIONAL AFFILIATE REPORTS THE FOLLOWING POSSIBLE BATCH NUMBERS: RBMMLP AND RBMMRH: BATCH# RBMMLP, MFG. DATE FEB/26/2021; EXP. DATE JAN/31/2026. BATCH# RBMMRH, MFG. DATE FEB/26/2021; EXP. DATE JAN/31/2026. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS FOR THE POSSIBLE BATCH NUMBERS WAS CONDUCTED AND NO NON-CONFORMANCES RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT THE LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: PATIENT INFORMATION: SEX: MALE, AGE: (B)(6) YEARS OLD. DETAILED DIAGNOSIS INFORMATION OF THE PATIENT: MYELOBULBAR GRANULOMA, QUADRIPLEGIA. SPECIFIC SURGERY: MEDULLA OBLONGATA OCCUPYING RESECTION VCP714D USED IN SKIN AND MUSCLE; VCP433H USED IN DURA MATER, PERIOSTEUM NOT SEWED. SPECIFIC INFORMATION OF BULGING SITE: BULGING BULGE AT THE WOUND, LOCATION: DIRECTLY BEHIND THE FIRST AND SECOND CERVICAL VERTEBRAE, SOFT, NO SECRETIONS, CONCOMITANT SYMPTOMS: LUNG INFECTION, SPUTUM, MALNUTRITION. RELEVANT INFORMATION OF THE SECOND OPERATION: IN THE SECOND OPERATION, THE ARTIFICIAL MENINGES AND THE DURA MATER WERE NOT HEALED WELL AND THERE WAS A LARGE GAP, AND THE ABSORBABLE SUTURES USED WERE ABSORBED COMPLETELY, ONLY ONE SILK THREAD IS CONNECTED AT THE FIXED POSITION AND THERE WAS NO TEARING AND CUTTING PHENOMENON. JUDGEMENT OF WOUND DEHISCENCE: THE CONDITION FOUND WHEN THE DOCTOR OPENED THE WOUND IN THE SECOND OPERATION, DUE TO A TEAR IN THE DURAL SUTURE, CEREBROSPINAL FLUID OVERFLOW, AND A SWELLING OF THE WOUND APPEARED. CURRENT STATE OF THE PATIENT: THE PATIENT DIED, THE MAIN DIAGNOSTIC REASONS ARE: BLEEDING, NO MEDICAL DISPUTES. WHAT IS AN ACTUAL LOT NUMBER OF VCP433H USED IN THE INDEX SURGERY AND INVOLVED IN THE EVENT? - UNKNOWN. PLEASE SPECIFY IF THESE TWO LOTS RBMMLP AND RBMMRH WERE REPORTED AS POSSIBLE LOTS? - YES, THESE TWO LOTS WERE REPORTED AS POSSIBLE LOTS. OR BOTH LOTS WERE USED IN DURA MATTER AND INVOLVED IN THE EVENT? - NO. IT WAS REPORTED THAT ¿ABSORBABLE SUTURES USED WERE ABSORBED COMPLETELY¿. HOW MANY VCP433H SUTURES WERE USED IN DURA MATTER AND FOUND ABSORBED COMPLETELY DURING RE-OPERATION? - DETAIL IS UNKNOWN, JUST REPORTED ONE PACKAGE. WAS THERE ANY ALLEGED DEFICIENCY OF VCP714D USED IN SKIN AND MUSCLE? IS THIS PRODUCT CODE ALSO INVOLVED IN THE EVENT? IF YES, PLEASE SPECIFY. - NO ISSUE WAS REPORTED FOR VCP714D. ATTEMPTS ARE BEING MADE TO CLARIFY 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. WAS A CAUSE OF DEATH REPORTED WITHIN THE MEDICAL RECORD OR DESCRIBED IN AN AUTOPSY REPORT? IF SO, PLEASE SPECIFY. DATE OF THE PATIENT¿S DEATH? TRADE NAME - IRGACARE®. ACTIVE INGREDIENT(S) ¿ TRICLOSAN. DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. STRENGTH = 275 UG/M.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A MEDULLA OBLONGATA OCCUPYING RESECTION PROCEDURE ON (B)(6) 2021 AND THE SUTURE WAS USED IN DURA MATER, PERIOSTEUM WAS NOT SEWED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AFTER SURGERY. HOWEVER, ON (B)(6) 2021, IT FOUND BULGING ON CRANIAL SURGICAL SITE; BULGING BULGE AT THE WOUND DIRECTLY BEHIND THE FIRST AND SECOND CERVICAL VERTEBRAE, SOFT WITH NO SECRETIONS. IT WAS REPORTED THAT CONCOMITANT SYMPTOMS WERE LUNG INFECTION, SPUTUM AND MALNUTRITION. AND THEN IT TOOK THE SECOND OPERATION ON (B)(6) 2021, AND NO SUTURE WAS FOUND ON THE DURAL SEWING SITE DURING RE-OPERATION. ANOTHER LIKE SUTURE WAS USED TO RE-SUTURE AGAIN. THE HOSPITAL CONSIDER THAT THE SUTURE ABSORBED COMPLETELY, TOO FAST, AND THEN WOUND SPLIT, THAT IS WHY IT NEEDED SUCH SECOND OPERATION ON (B)(6) 2021. IN THIS SECOND OPERATION, THE ARTIFICIAL MENINGES AND THE DURA MATER WERE NOT HEALED WELL AND THERE WAS A LARGE GAP, AND THE ABSORBABLE SUTURES USED WERE ABSORBED COMPLETELY, ONLY ONE SILK THREAD WAS CONNECTED AT THE FIXED POSITION AND THERE WAS NO TEARING AND CUTTING PHENOMENON. THE CONDITION FOUND WHEN THE DOCTOR OPENED THE WOUND IN THE SECOND OPERATION, DUE TO A TEAR IN THE DURAL SUTURE, CEREBROSPINAL FLUID OVERFLOW, AND A SWELLING OF THE WOUND APPEARED. THE PATIENT WAS TRANSFERRED TO ICU. THE PATIENT DIED AND THE MAIN DIAGNOSTIC REASONS ARE BLEEDING, NO MEDICAL DISPUTES. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1451613 VCL+ UD 27IN 5-0 S/A TF SUTURE, ABSORBABLE, SYNTHETIC GAM ETHICON INC. VCP433H 10705031053199

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death| R