BEUDAMED
    FDA Adverse Event Death Summary report: N

    DISIMPACTOR(3) W/EXTENSION SET

    MDR report key: 12860020 · Received November 23, 2021

    Report

    Report Number
    1417592-2021-00211
    Event Type
    Death
    Date Received
    November 23, 2021
    Date of Event
    August 22, 2021
    Report Date
    November 23, 2021
    Manufacturer
    MEDLINE INDUSTRIES LP
    Product Code
    FHB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE DISIMPACTOR HAD BEEN INSERTED ONCE, REMOVED AND WAS BEING INSERTED A SECOND TIME WHEN THE EVENT OCCURRED. THE PHYSICIAN STATED THAT THE PATIENT HAD A STOOL IMPACTION THAT WAS NOT TREATABLE BY ENEMA AND HE DID NOT TOLERATE A DIGITAL DISIMPACTION. THE DISIMPACTOR DEVICE WAS USED ALONG WITH AN ENEMA AND THERE WAS SOME OUTPUT OF STOOL BALLS. THE DISIMPACTOR WAS THEN GENTLY REINSERTED AND A SECOND ENEMA WAS RE-INSTILLED. UPON REMOVING THE DISIMPACTED AIR A LARGE AMOUNT OF BRIGHT RED BLOOD CAME FROM THE RECTUM AND THE PROCEDURE WAS IMMEDIATELY STOPPED. A COMPUTERIZED TOMOGRAPHY (CT) SCAN REVEALED RECTAL PERFORATION, THE PATIENT BECAME HYPOTENSIVE AND WAS GIVEN PACKED RED BLOOD CELLS (PRBCS) AND SURGERY WAS CONSULTED. ULTIMATELY THE FAMILY DECIDED THAT COMFORT CARE WAS MOST IN LINE WITH THE PATIENT'S WISHES AND HE WAS TRANSITIONED TO HOSPICE AND ULTIMATELY PASSED AWAY. THE CAUSE OF DEATH WAS LISTED AS LOWER GASTROINTESTINAL (GI) HEMORRHAGE DUE TO BOWEL PERFORATION DURING ATTEMPTS AT FECAL DISIMPACTION. THE SAMPLE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE DISIMPACTOR HAD BEEN INSERTED ONCE, REMOVED AND WAS BEING INSERTED A SECOND TIME WHEN THE PATIENT BEGAN TO HEMORRHAGE DUE TO BOWEL PERFORATION. AFTER NUMEROUS INTERVENTIONS THE PATIENT ULTIMATELY PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1759267 DISIMPACTOR(3) W/EXTENSION SET FHB MEDLINE INDUSTRIES LP

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Death