BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 14598668 · Received June 3, 2022

    Report

    Report Number
    2210968-2022-04295
    Event Type
    Death
    Date Received
    June 3, 2022
    Date of Event
    June 28, 2021
    Report Date
    August 4, 2022
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THIS REPORT IS RELATED TO A JOURNAL ARTICLE, THEREFORE NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE MANUFACTURING RECORD EVALUATION CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? FOR THE (B)(6) PATIENT DESCRIBED IN FIGURE 6, PLEASE CONFIRM IF SURGIFLO WAS USED? FOR THE (B)(6) PATIENT DESCRIBED IN FIGURE 4, PLEASE CONFIRM IF SURGIFLO WAS USED? WHEN SURGIFLO WAS USED IN A PATIENT, WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED?

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE PATIENT CONSEQUENCES DESCRIBED IN THE ARTICLE? THE AUTHOR RESPONDED THAT THE ARTICLE DOESN'T MENTION ANY SPECIFIC PROBLEMS WITH ETHICON PRODUCT. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: 1. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER(S). 2. DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON PRODUCTS USED IN THIS PROCEDURE? 3. WAS THERE ANY MEDICAL OR SURGICAL INTERVENTION PERFORMED (PRODUCT REMOVED; RE-OPERATION; RE-CLOSURE; PRESCRIPTION STEROIDS; ANTIBIOTICS PRESCRIBED)? IF SO, PLEASE CLARIFY. 4. CAN YOU IDENTIFY THE PRODUCT CODE AND LOT NUMBER OF THE PRODUCT THAT WAS USED IN EACH PROCEDURE? 5. CAN SPECIFIC PATIENT DEMOGRAPHICS INITIALS / ID; DATE OF BIRTH; BMI; GENDER; PATIENT PRE-EXISTING MEDICAL CONDITIONS (I.E. ALLERGIES, HISTORY OF REACTIONS), ALL CONCOMITANT MEDICATIONS, PAST MEDICAL HISTORY, ANY TREATMENT REQUIRED FOR EVENTS, DOSE, FREQUENCY, AND THERAPY DATES OF STUDY DRUGS BE PROVIDED? 6. FOR THE 59-YEAR OLD PATIENT DESCRIBED IN FIGURE 6, PLEASE CONFIRM IF SURGIFLO WAS USED? 7. FOR THE 62-YEAR OLD PATIENT DESCRIBED IN FIGURE 4, PLEASE CONFIRM IF SURGIFLO WAS USED? 8. WHEN SURGIFLO WAS USED IN A PATIENT, WAS SURGIFLO REMOVED AFTER HEMOSTASIS WAS ACHIEVED? CITATION CITE: DOI 10.25259/SNI_458_2021QINGDAO MEDICAL JOURNAL 2021 YEAR 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

    IT WAS REPORTED VIA A JOURNAL ARTICLE: TITLE: SHORT-TERM OUTCOMES OF ENDOSCOPIC EVACUATION OF SUPRATENTORIAL SPONTANEOUS INTRACEREBRAL HEMATOMA: EARLY EXPERIENCE FROM DEVELOPING COUNTRY. AUTHORS: MOHAMMAD ELBAROODY, MOHAMED ADEL GHONEIM, AHMED EL FIKI, HESHAM HOZAYEN, WAEL EL-MAHDY. CITATION CITE: DOI 10.25259/SNI_458_2021QINGDAO MEDICAL JOURNAL 2021 YEAR. WE RETROSPECTIVELY COLLECTED THE DATA OF 15 PATIENTS WHO UNDERWENT ENDOSCOPIC EVACUATION OF SPONTANEOUS SUPRATENTORIAL INTRACEREBRAL HEMATOMA BETWEEN NOVEMBER 2018 AND MARCH 2020 IN OUR INSTITUTE. INCLUSION CRITERIA WERE ADULT PATIENTS 18¿70 YEARS WITH GCS (4¿14) AND ONE OF THE FOLLOWING: BASAL GANGLIA ICH WITH A HEMATOMA VOLUME >30 CC; OR SUBCORTICAL HEMORRHAGE > 30 CC WITH A SIGNIFICANT MASS EFFECT (MIDLINE SHIFT >5 MM AND SULCUS EFFACEMENT); OR THALAMIC ICH WITH A HEMATOMA VOLUME >20 CC AND ACUTE HYDROCEPHALUS; OR COMBINED TYPE ICH OR LARGE HEMATOMA OCCUPYING BOTH THE BASAL GANGLIA AND THE THALAMUS. WE USED SMALL SURGICEL® (ETHICON INC., (B)(4) USA) MICRO PIECES OVER THE OOZING WALL OF HEMATOMA AND WE ALSO USED SURGIFLO® (ETHICON INC., (B)(4) USA) IN SOME CASES IF AVAILABLE. REPORTED COMPLICATIONS INCLUDED A (B)(6) MALE PATIENT STAYED IN THE HOSPITAL FOR 3 DAYS THEN DIED DUE TO SEPSIS, HEMATOMA. IN CONCLUSION ENDOSCOPIC TECHNIQUE IS A SAFE SURGICAL OPTION FOR EVACUATION OF SPONTANEOUS SUPRATENTORIAL ICH. FOR CERTAIN PATIENTS, THIS MINIMALLY INVASIVE APPROACH CAN BE BENEFICIAL IN TERMS OF IMPROVING SHORT-TERM OUTCOMES. IN OUR EXPERIENCE, THIS MINIMALLY INVASIVE PROCEDURE HAD LITTLE IMPACT ON THE OUTCOME OF CASES WITH A LOW GCS AT THE TIME OF ADMISSION, THAT IS, 4/15. THIS TECHNIQUE NECESSITATES A STEEP LEARNING CURVE, IMPLYING THE ACQUISITION OF SKILLS. AS A RESULT, FAMILIARITY WITH THE ENDOSCOPE AND ASSOCIATED INSTRUMENTATION IS THE MOST EFFECTIVE WAY TO ACHIEVE A BETTER RESULT WITH LESS COMPLICATION. OUR FINDINGS CALL FOR A PROSPECTIVE, RANDOMIZED, CONTROLLED EFFICACY TRIAL IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801857 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Death| R