BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3005099803-2019-06159

    MDR report key: 9485006 · Received December 17, 2019

    Report

    Report Number
    3005099803-2019-06159
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    October 1, 2019
    Report Date
    December 17, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    KGE
    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, 4 DAYS POST PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH EPIGASTRIC PAIN, COFFEE GROUND VOMIT, AND MELAENA. ANOTHER OGD WAS PERFORMED AND IT WAS NOTED THAT THE DUODENAL BIOPSY SITES WERE BLEEDING. 3 CLIPS WERE PLACED TO TREAT THE BLEEDING. REPORTEDLY, THE BLEEDING WAS THOUGHT TO BE DUE TO ALCOHOL EXCESS. 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
    1272198 KGE BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R