BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REALIZE ADJ GASTRIC BAND-C

    MDR report key: 1713358 · Received June 8, 2010

    Report

    Report Number
    3005992282-2010-00158
    Event Type
    Injury
    Date Received
    June 8, 2010
    Date of Event
    March 23, 2010
    Report Date
    May 17, 2010
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). (B) (4). INFORMATION UNAVAILABLE, DEVICE NOT RETURNED FOR ANALYSIS. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CONSUMER THAT SHE IS UNABLE TO TOLERATE FOODS AND HAS BEEN VOMITING SINCE GASTRIC BAND IMPLANT. SHE ALSO REPORTED THAT A FOLLOW UP PROCEDURE WAS PERFORMED TO REMOVE THE BAND EXTENDER. THIS DID NOT RESOLVE HER SYMPTOMS. CONSUMER REPORTED THAT SHE HAS BEEN TO THE EMERGENCY ROOM SEVERAL TIMES DUE TO VOMITING. IN A CONVERSATION WITH THE CONSUMER ON (B) (4) 2010 SHE ADVISED THAT SHE CONTINUES TO HAVE ISSUES WITH KEEPING FOOD DOWN. SHE STATES THAT SHE WAS HOSPITALIZED (B) (6) THROUGH (B) (6) BECAUSE OF THIS ISSUE AND DEHYDRATION. DURING THE HOSPITAL STAY, THE PATIENT WAS GIVEN TPN, BUT IT WAS DISCONTINUED WHEN SHE WAS DISCHARGED HOME. PER THE PATIENT, SHE HAS SEEN THE IMPLANTING SURGEON AND HE TOLD HER "YOU ARE JUST A CRY BABY" "YOU NEED TO DEAL WITH IT OR HAVE THE BAND REMOVED". THE IMPLANTING SURGEON HAS SCOPED HER THREE TIMES AND STATES THE BAND IS IN PLACE, NO RUPTURES SEEN. ACCORDING THE CONSUMER, THE SURGEON IS TELLING HER THAT SHE IS EATING THE WRONG FOODS AND DRINKING TOO FAST. SHE DISAGREES WITH HIM SINCE SHE IS UNABLE TO TOLERATE FOODS. SHE HAS NOT HAD ANY FILLS. SHE INDICATED THAT HER INTERNAL MEDICINE DOCTOR HAS TOLD HER THAT SHE HAS A NARROWING OF THE ESOPHAGUS AND RECOMMENDED THAT SHE GET A SECOND OPINION REGARDING THE BAND. CONSUMER IS ADAMANT ABOUT KEEPING THE BAND AS SHE STATES SHE NEEDS TO LOSE WEIGHT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REALIZE ADJ GASTRIC BAND-C IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Hospitalization