BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOK PERITONEAL LAVAGE SET

    MDR report key: 8171793 · Received December 17, 2018

    Report

    Report Number
    1820334-2018-03830
    Event Type
    Malfunction
    Date Received
    December 17, 2018
    Date of Event
    August 29, 2016
    Report Date
    December 17, 2018
    Manufacturer
    COOK INC
    Product Code
    GBW
    UDI-DI
    00827002052673
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMMON NAME: CATHETER, PERITONEAL. PRODUCT CODE: GBW. THIS MDR IS BEING FILED AFTER THE ASSOCIATED COMPLAINT WAS REVIEWED UNDER REMEDIATION PROTOCOL (B)(4), COMPLAINT/MDR RETROSPECTIVE REVIEW AND REMEDIATION AND REASSESSED AS REPORTABLE. ADDITIONAL COMPLAINT INVESTIGATION AND RECORD REMEDIATION WAS NOT PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE PERITONEAL LAVAGE CATHETER WAS LEAKING ON THE SURFACE OF THE ABDOMEN. A CRACK/TEAR WAS FOUND AT THE ROOT OF THE CATHETER. IT WAS FURTHER NOTED THAT THE CATHETER HAD A HOLE NEAR THE HUB. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER. NO OTHER INFORMATION WAS MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1012052 COOK PERITONEAL LAVAGE SET GBW COOK INC NA 5870318 00827002052673

    Patients

    Seq Age Sex Outcome Treatment
    1