BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLAKE DRAIN UNKNOWN PRODUCT

    MDR report key: 11629718 · Received April 7, 2021

    Report

    Report Number
    2210968-2021-03106
    Event Type
    Malfunction
    Date Received
    April 7, 2021
    Date of Event
    February 25, 2021
    Report Date
    March 16, 2021
    Manufacturer
    ETHICON INC.
    Product Code
    GBX
    PMA / PMN Number
    CL I EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). THIS COMPLAINT WAS RECEIVED DIRECTLY FROM (B)(6), THEREFORE NO FURTHER INFORMATION CAN BE OBTAINED BEYOND WHAT IS DESCRIBED IN THIS COMPLAINT FORM. PRODUCT: DRAIN / BATCH: 1170759, LOT/BATCH 1170759. REPORTED IS NOT A VALID LOT FOR ETHICON BLAKE DRAINS PRODUCTS. POSSIBLE THIS IS NOT AN ETHICON PRODUCT. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021, AND A DRAIN WAS USED. DRAIN RUPTURED DURING THE PROCEDURE. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526123 BLAKE DRAIN UNKNOWN PRODUCT CATHETER, IRRIGATION GBX ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1