BEUDAMED
    FDA Adverse Event Death Summary report: N

    ORBERA GASTRIC BALLOON

    MDR report key: 17528433 · Received August 12, 2023

    Report

    Report Number
    MW5135363
    Event Type
    Death
    Date Received
    August 12, 2023
    Date of Event
    February 23, 1962
    Report Date
    October 5, 2017
    Manufacturer
    APOLLO ENDOSURGERY, INC
    Product Code
    LTI
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    RECEIVED VOLUNTARY MEDWATCH (MW5071866) REPORTING: "THIS CONSUMER VOLUNTARY REPORT IS SUBMITTED ON BEHALF OF A PATIENT WHO HAD THE ORBERA GASTRIC BALLOON PLACED ON OR ABOUT (B)(6) 2017 BY (B)(6) OF (B)(6). EITHER IN HIS OFFICE OR AT (B)(6). THE PATIENT REPORTED SEVERE PAIN TO THE TREATING PHYSICIAN AND HAD EMERGENT SURGERY ON OR ABOUT (B)(6) 2017 AT (B)(6) FOR REMOVAL OF THE BALLOON AND REPAIR OF A PERFORATION OF THE STOMACH WALL. THE PATIENT CONTINUED TO SUFFER FROM COMPLICATIONS FROM THE PERFORATION, INFECTION AND SURGICAL REPAIR, UNDERGOING SUBSEQUENT SURGICAL INTERVENTION AND WAS TRANSFERRED TO (B)(6) FOR LIFE-THREATENING COMPLICATIONS ON OR ABOUT (B)(6) 2017. THE PATIENT EXPIRED ON (B)(6) 2017." FOLLOW UP FINDINGS WITH THE PHYSICIAN: THE PATIENT WAS NOT IMPLANTED WITH AN ORBERA DEVICE. (B)(4). THIS REPORT REFLECTS INFORMATION RECEIVED BY FDA IN THE FORM OF A NOTIFICATION PER 803.22 (B)(2)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    869364 ORBERA GASTRIC BALLOON IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI APOLLO ENDOSURGERY, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown