BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADJ GASTRIC BAND

    MDR report key: 4751562 · Received May 6, 2015

    Report

    Report Number
    3005992282-2015-00019
    Event Type
    Injury
    Date Received
    May 6, 2015
    Date of Event
    April 8, 2015
    Report Date
    April 24, 2015
    Manufacturer
    OBTECH MEDICAL SARL_
    Product Code
    LTI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RETURNED FOR ANALYSIS SHOULD THE INFORMATION BE PROVIDED LATER, A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT IS THE PATIENT¿S CURRENT STATUS? DISCHARGED. WHAT PIECE IS MISSING FROM THE DEVICE? WHAT COMPONENT OF THE DEVICE IS SAID TO REMAIN INSIDE THE PATIENT? STRAIN RELIEF. WHAT EVENTS LED TO THE DECISION MADE TO LEAVE THE MISSING COMPONENT INSIDE THE PATIENT? PATIENT RETURNED FOR RE-OP AND PIECE REMOVED ON (B)(6) 2015. HAS THE EXPLANTED DEVICE BEEN DISCARDED OR CAN THIS BE RETURNED FOR INVESTIGATION? NO. WHAT DATE WAS THE DEVICE IMPLANTED? (B)(6) 2010. WHAT DATE IS THE NEXT SURGERY SCHEDULED FOR? (B)(6) 2015.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON EVALUATION OF THE PHOTOGRAPHY, IT WAS OBSERVED THAT THE INJECTION PORT WAS IN THE LOCKED POSITION, HOOKS WERE DEPLOYED AND THE LOCKING CONNECTOR WAS IN PLACE. THE TUBING STRAIN RELIEF WAS NOT PRESENT ON THE LOCKING CONNECTOR. THE STRAIN RELIEF MATERIAL IS IDENTIFIED AS SILICONE, AND IS CERTIFIED BY THE MANUFACTURER TO BE SUITABLE FOR USE IN IMPLANT DEVICES. THIS SILICONE MATERIAL HAS BEEN TESTED FOR LONG TERM IMPLANTABILITY.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A LAPAROSCOPIC BAND REMOVAL PROCEDURE, A PIECE OF THE DEVICE FELL OFF IN THE PATIENT WHEN REMOVING IT TWO WEEKS AGO. THE PATIENT WAS NOW COMPLAINING OF ABDOMINAL PAIN. THE CT SCAN SHOWED A MASS WHERE THE PIECE WAS SUPPOSED TO BE AND THE ULTRASOUND REVEALED JUST A POTENTIAL CALCIFICATION TUBULAR. THE SURGEON IS GOING TO SCHEDULE THE PATIENT FOR RE-OPERATION TO REMOVE THE ITEM THAT FELL OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296073 ADJ GASTRIC BAND IMPLANT, INTRAGASTRIC FOR MORBID OBESITY LTI OBTECH MEDICAL SARL_ NA ZKDBLZ

    Patients

    Seq Age Sex Outcome Treatment
    1