BEUDAMED
    FDA Adverse Event Other Summary report: N

    PEG, S.P. PULL, 20CH - EURO

    MDR report key: 1905857 · Received November 12, 2010

    Report

    Report Number
    1314412-2010-00006
    Event Type
    Other
    Date Received
    November 12, 2010
    Date of Event
    October 11, 2010
    Report Date
    October 19, 2010
    Manufacturer
    COVIDIEN
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A GASTRIC TUBE. THE CUSTOMER REPORTED THE PT WAS FITTED WITH A GASTRIC TUBE ON (B)(6) 2010, AFTER A BLOOD TEST THE RESULTS SHOW THE PT HAS ACUTE ANEMIA WITH A SUSPICION OF A GASTRIC ULCER. AN ENDOSCOPY REVEALS A FIBROUS ULCER AT THE ENTRY OF THE GASTRIC TUBE. THE RETENTION BOLSTER OF THE GASTRIC TUBE WAS IMPACTED IN THE TISSUE. THE SURGEON LOOSENED THE GASTRIC TUBE TO ALLOW THE TISSUE TO HEAL. THE CUSTOMER REPORTS, IF THE PT'S ACUTE ANEMIA PERSISTS, THE GASTRIC TUBE WILL BE REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PEG, S.P. PULL, 20CH - EURO GASTRIC TUBE KNT COVIDIEN 8884752075 A1000641

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other