BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPIREASSIST A-TUBE

    MDR report key: 9488413 · Received December 18, 2019

    Report

    Report Number
    3009595931-2019-00002
    Event Type
    Injury
    Date Received
    December 18, 2019
    Date of Event
    November 12, 2019
    Report Date
    December 17, 2019
    Manufacturer
    ASPIRE BARIATRICS, INC.
    Product Code
    OYF
    UDI-DI
    10857808005471
    PMA / PMN Number
    P150024
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT UNDERWENT A "PULL" PERCUTANEOUS ENDOSCOPIC PLACEMENT OF THE A-TUBE. DURING THIS PROCEDURE, PROPHYLACTIC ANTIBIOTICS ARE GIVEN TO THE PATIENT. THE PATIENT WAS SUCCESSFUL IMPLANTED WITHOUT ANY ISSUES OR CONCERNS AND SENT HOME TO RECOVER. PATIENT WAS SEEN 1 WEEK LATER AND THE STOMA SITE OBSERVED, STAFF INDICATED THE SITE LOOKED GOOD. APPROXIMATELY ONE MONTH AFTER THAT VISIT THE PATIENT RETURNED FROM TRAVEL AND CONTACTED THE PHYSICIAN. PATIENT WAS ADMITTED TO THE HOSPITAL AND STARTED ON IV ANTIBIOTICS. A HEPATIC ABSCESS WAS DIAGNOSED AND TEE PERFORMED. THE ABSCESS WAS CULTURED AND FOUND TO BE STREP INTERMEDIUS. PATIENT REMAINED IN THE HOSPITAL FOR 16 DAYS AND WAS DISCHARGED TO HOME CARE AND CONTINUED ANTIBIOTIC TREATMENT UNTIL (B)(6) 2020. PATIENT IS EXPECTED TO MAKE A FULL RECOVERY.

    Description of Event or Problem · 1

    PATIENT WAS IMPLANTED WITH GASTROSTOMY TUBE (A-TUBE). APPROXIMATELY 6 WEEKS LATER PRESENTED WITH HEPATIC ABSCESS SECONDARY TO STREP INTERMEDIUS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1283860 ASPIREASSIST A-TUBE GASTROSTOMY TUBE OYF ASPIRE BARIATRICS, INC. NA F101196 10857808005471

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization