BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TC MAYO-HEGAR NDL HOLDERHVYSERR205MM

    MDR report key: 12739301 · Received November 2, 2021

    Report

    Report Number
    2916714-2021-00213
    Event Type
    Injury
    Date Received
    November 2, 2021
    Date of Event
    December 7, 2021
    Report Date
    December 23, 2021
    Manufacturer
    AESCULAP AG
    Product Code
    HXK
    UDI-DI
    04038653028276
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 - DESCRIPTION UPDATED. H6 - UPDATED CODES.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: AS OF THE DATE OF THIS REPORT THE COMPLAINT PRODUCT WAS NOT PROVIDED FOR INVESTIGATION. THEREFORE, A THOROUGH INVESTIGATION IS NOT POSSIBLE. BATCH HISTORY REVIEW: DUE TO THE FACT THAT NEITHER AN ARTICLE NUMBER NOR A LOT NUMBER WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS MUST REMAIN INCOMPLETE. CONCLUSION AND MEASURES / PREVENTIVE MEASURES: BASED UPON THE INVESTIGATION RESULTS A CLEAR ROOT CAUSE CONCLUSION CANNOT BE DRAWN. THERE IS NO INDICATION FOR A MATERIAL-, MANUFACTURING- OR DESIGN-RELATED FAILURE. IN THE EVENT THAT THE COMPLAINT PRODUCT WILL BE PROVIDED FOR INVESTIGATION IN THE FUTURE, AN UPDATE OF THIS REPORT WILL BE PROVIDED UNSOLICITED. BASED UPON THE INVESTIGATIONS RESULTS A CAPA IS NOT NECESSARY.

    Description of Event or Problem · 0

    CLARIFICATION WAS RECEIVED: THERE WAS NO DELAY CAUSED BY THE BREAKAGE IN THE ORIGINAL SURGERY. HOWEVER, POSTOPERATIVELY, THE PATIENT UNDERWENT ANOTHER PROCEDURE (NOT SPECIFIED), AS WELL AS ATTENDING MULTIPLE PHYSICIAN APPOINTMENTS, AND REQUIRED THE PERFORMANCE OF ADDITIONAL X-RAYS.

    Description of Event or Problem · 0

    NO UPDATES.

    Additional Manufacturer Narrative · 1

    MANUFACTURING SITE EVALUATION: ADDITIONAL INFORMATION / INVESTIGATION RESULTS WILL BE PROVIDED IN A SUPPLEMENTAL REPORT, IF AVAILABLE. MEDWATCH REPORT # 450015000-2021-8015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ISSUE WITH BM067R - TC MAYO-HEGAR NDL HOLDERHVYSERR205MM. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING CESAREAN SECTION PROCEDURE PART OF A NEEDLE DRIVER INSERT FELL INTO A PATIENT. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. THE ADVERSE EVENT IS FILED UNDER (B)(4) REFERENCE (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1635721 TC MAYO-HEGAR NDL HOLDERHVYSERR205MM DUROGRIP NEEDLEHOLDERS HXK AESCULAP AG BM067R 04038653028276

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Female Required Intervention