BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICEL ABSORBABLE HEMOSTAT UNKNOWN

    MDR report key: 16915523 · Received May 11, 2023

    Report

    Report Number
    2210968-2023-03540
    Event Type
    Injury
    Date Received
    May 11, 2023
    Report Date
    May 11, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    LMG
    PMA / PMN Number
    N12159
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6. COMPONENT CODE: G07002 - DEVICE NOT RETURNED. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. CAN SPECIFIC PATIENT DEMOGRAPHICS: INITIALS; AGE OR 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? CITATION: JOURNAL OF PEDIATRIC SURGERY CASE REPORTS 84 (2022) 102392. 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: EMERGENT EXCHANGE TRANSFUSION DURING SURGICAL RESECTION OF SACROCOCCYGEAL TERATOMA IN A NEONATE. AUTHOR: J.M. DAVIDSON, T. HEAD, M.F. WEEMS, J. JONES, Y. WEATHERALL. CITATION: JOURNAL OF PEDIATRIC SURGERY CASE REPORTS 84 (2022) 102392. WE PRESENT A CASE WHERE TYPICAL MEDICAL MANAGEMENT OF HYPERKALEMIA WAS UNSUCCESSFUL AND EMERGENT DECISION HAD TO BE MADE TO PERFORM EXCHANGE TRANSFUSION WHILE INFANT WAS UNDERGOING SURGICAL RESECTION WITH A GOOD OUTCOME. MATERNAL PRENATAL CARE COMMENCED AT 7 WEEKS OF GESTATION. AT 25 WEEKS OF GESTATION, THE MOTHER PRESENTED TO THE EMERGENCY DEPARTMENT WITH ABDOMINAL PAIN. THE FETUS WAS FOUND TO HAVE A SACROCOCCYGEAL MASS AND HIGH-RISK OBSTETRICS WAS CONSULTED. PRENATAL MONITORING OF THE MASS CONTINUED WITH MULTIPLE ULTRASOUNDS AND MRI AT 29 WEEKS THAT SHOWED AN 11 BY 8 BY 9 CM SACROCOCCYGEAL TERATOMA. THE PATIENT WAS BORN AT 30 WEEKS AND 6 DAYS VIA CESAREAN SECTION DUE TO DEVELOPING HYDROPS. THE PATIENT WAS INTUBATED IN THE DELIVERY ROOM. THE TERATOMA RUPTURED DURING DELIVERY, AND EXCESSIVE BLEEDING WAS TREATED WITH SURGICEL APPLICATION AND MANUAL COMPRESSION. PACKED RED BLOOD CELL TRANSFUSIONS (PRBC) WERE INITIATED, AND AFTER INITIAL STABILIZATION, SHE WAS TRANSPORTED TO THE CHILDREN¿S HOSPITAL OPERATING ROOM FOR EXPLORATORY LAPAROTOMY AND LIGATION OF THE MIDDLE SACRAL ARTERY. IN THE OPERATING ROOM, UNCONTROLLED HEMORRHAGE LED TO PROFOUND HYPOTENSION. TO CONTROL THE BLEEDING, THE MIDDLE SACRAL ARTERY WAS LIGATED VIA A TRANSABDOMINAL APPROACH, THE SOLID COMPONENTS OF THE TUMOR WAS PARTIALLY DECOMPRESSED THROUGH THE RUPTURED AREA, AND A PARTIAL RESECTION WAS PERFORMED USING A GASTROINTESTINAL STAPLER. SHE WAS DISCHARGED HOME AT 2 MONTHS OF AGE WITH OUTPATIENT ONCOLOGY FOLLOW-UP. SHE IS CURRENTLY 2 YEARS OLD AND RECEIVING CARE FROM OUR LOCAL PEDIATRIC ONCOLOGY HOSPITAL. IN CONCLUSION, SACROCOCCYGEAL TERATOMAS ARE RARE IN NEONATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424379 SURGICEL ABSORBABLE HEMOSTAT UNKNOWN AGENT, ABSORBABLE HEMOSTATIC, NON-COLLAGEN BASED LMG ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention