BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM

    MDR report key: 11819683 · Received May 13, 2021

    Report

    Report Number
    1644408-2018-00539
    Event Type
    Injury
    Date Received
    May 13, 2021
    Report Date
    December 7, 2020
    Product Code
    OQH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: ORIGINAL INITIAL REPORT WAS SUBMITTED AS FOLLOW UP IN ERROR.

    Description of Event or Problem · 1

    REVISION SURGERY - DUE TO THE PATIENT HAVING A POST OPERATIVE WOUND INFECTION. THE SURGEON DID AN IRRIGATION AND DRAINAGE (I&D) OF WOUND AND PROPHYLACTIC ALL SWAPPED HEAD AND LINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715786 LINER 10 HOODED NEU, MP6, HXE-PLUS, 32MM OQH 811N1949

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R