BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005099803-2019-06128

    MDR report key: 9484987 · Received December 17, 2019

    Report

    Report Number
    3005099803-2019-06128
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    July 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 RADIAL JAW 4 BIOPSY FORCEPS WAS USED IN THE DUODENUM DURING A OESOPHAGO-GASTRODUODENOSCOPY (OGD) PROCEDURE PERFORMED IN (B)(6) 2019. ACCORDING TO THE COMPLAINANT, THE DAY AFTER THE PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL REPORTING HAVING EXPERIENCED TWO EPISODES OF MELAENA. THE PATIENT WAS MONITORED AND A SMALL DROP OF HEMOGLOBIN WAS NOTED. A REPEAT BLOOD TEST WAS PERFORMED AND THE HEMOGLOBIN SHOWED NO FURTHER DROP. THE PATIENT WAS DISCHARGED ONE DAY LATER. ADDITIONALLY, THE PATIENT WAS GIVEN HIGH DOSE PROTON PUMP INHIBITORS (PPI) FOLLOWING THE OGD PROCEDURE AND WAS SCHEDULED FOR ANOTHER OGD IN SIX TO EIGHT WEEKS. BOSTON SCIENTIFIC HAS BEEN UNABLE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT TO DATE, DESPITE GOOD FAITH EFFORTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272562 FCL BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization