BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005099803-2019-06156

    MDR report key: 9485067 · Received December 17, 2019

    Report

    Report Number
    3005099803-2019-06156
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    March 1, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCL
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT DATE OF THE EVENT IS UNKNOWN. THE PROVIDED EVENT DATE WAS CHOSEN AS A BEST ESTIMATE BASED ON THE REPORTED DATE OF (B)(6) 2019. THE COMPLAINANT WAS UNABLE TO REPORT THE DEVICE BRAND NAME, UPN AND LOT NUMBER; THEREFORE THE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A BOSTON SCIENTIFIC COLONIC BIOPSY FORCEPS WAS USED DURING AN OESOPHAGO-GASTRODUODENOSCOPY (OGD) PROCEDURE PERFORMED IN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, A DAY POST PROCEDURE, THE PATIENT EXPERIENCED HAEMATEMESIS AND PRESENTED TO THE EMERGENCY DEPARTMENT. ACCORDING TO THE GASTROENTEROLOGIST, THE HAEMATEMESIS WAS SECONDARY TO POST BIOPSY BLEEDING FROM THE OGD PROCEDURE, AS THE PATIENT WAS TAKING ASPIRIN. BLOOD TESTS WERE TAKEN AND DID NOT SHOW ANY DROP OF HAEMOGLOBIN OR RISE IN UREA. THE PATIENT'S CONDITION REMAINED STABLE WITH NO FURTHER EPISODES OF BLEEDING. THE PATIENT WAS DISCHARGED WITH PLANNED FOLLOW-UP TO EVALUATE THE HAEMOGLOBIN LEVELS, HAEMATINICS AND TO CONSIDER IRON INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1277000 FCL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization