BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORKSCREW INSTRUMENT

    MDR report key: 13666933 · Received March 3, 2022

    Report

    Report Number
    MW5107889
    Event Type
    Malfunction
    Date Received
    March 3, 2022
    Date of Event
    February 10, 2022
    Report Date
    March 2, 2022
    Manufacturer
    UNK
    Product Code
    HWI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    (B)(6) 71-5210 100221 CORKSCREW INSTRUMENT AND IT BROKE INTO 2 PIECES INSIDE PATIENT'S PELVIS. BOTH PIECES WERE RETRIEVED WITH NO COMPLICATIONS OR HARM TO PATIENT. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    47338 CORKSCREW INSTRUMENT CORKSCREW HWI UNK 71-5210 100221 71-5210 100221

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female