BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GYNECARE UNKNOWN PRODUCT

    MDR report key: 20251574 · Received September 18, 2024

    Report

    Report Number
    2210968-2024-09965
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    May 22, 2024
    Manufacturer
    ETHICON INC.
    Product Code
    OTO
    PMA / PMN Number
    K013718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) 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 INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, 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. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNEVENTFUL DA VINCI-ASSISTED NERVE SPARING COLPOSACROPEXY WITH MESH INTERPOSITION WITH POSTERIOR COLPORRHAPHY. THE PATIENT EXPERIENCED POST-OPERATIVE BLEEDING THAT REQUIRED REOPERATION AND A CARDIAC EVENT THAT ELUTING STENTS WERE PLACED. THE NEXT DAY, THE PATIENT WAS REPORTED AS UNSTABLE WITH HER HEMOGLOBIN DROPPED AND AN EMERGENT LAPAROSCOPIC SURGERY WAS PERFORMED. A HEMORRHAGE AROUND THE FIXATION SITE OF THE COLPOSACROPEXY MESH ON THE LONGITUDINAL ANTERIOR LIGAMENT WAS OBSERVED. THREE UNITS OF ERYTHROCYTE CONCENTRATES WERE REQUIRED. HEMOSTASIS BY ELECTROCOAGULATION AND COMPRESSION AROUND THE ANTERIOR LONGITUDINAL LIGAMENT AND SUBSEQUENT CLOSURE OF THE PERITONEUM WITH A VLOC SUTURE WAS PERFORMED. ON THE SAME DAY, THE PATIENT WENT INTO A CARDIOGENIC SHOCK AND EXPERIENCED A NON-ST ELEVATION MYOCARDIAL INFARCTION. A SEVERE CORONARY 3 VESSEL DISEASE WAS DIAGNOSED WHERE TWO DRUG ELUTING STENTS WERE PLACED. NO FURTHER INFORMATION IS AVAILABLE AS THE INITIAL REPORTER IS CONFIDENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2464153 GYNECARE UNKNOWN PRODUCT MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC OTO ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention