BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LL100 WITH PINNED YOKE

    MDR report key: 15085440 · Received July 22, 2022

    Report

    Report Number
    1216677-2022-00213
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 20, 2022
    Report Date
    July 22, 2022
    Manufacturer
    COOPERSURGICAL, INC.
    Product Code
    GEH
    PMA / PMN Number
    K803311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Additional Manufacturer Narrative · 0

    FOLLOW UP: 8/4/2022. CORRECTED DATA: SUBMISSION NAME - 1216677-2022-00213 LL100 WITH PINNED YOKE 900019-70 (B)(4). D1 BRAND NAME: LL100 WITH PINNED YOKE. D2 COMMON NAME: LL100. D4 MODEL NUMBER: 900019-70. CATALOG NUMBER: 900019-70. INITIAL 7/22/2022. THE REPORTED CONDITION IS CURRENTLY BEING INVESTIGATED.

    Description of Event or Problem · 0

    LEAKS. LOG 98746. UNIT CAME IN FROM (B)(4) DISTRIBUTOR. LL100 CRYO FRZ NO GAS 900019 (B)(4).

    Description of Event or Problem · 0

    LEAKS. LOG: (B)(4). UNIT CAME IN FROM UK DISTRIBUTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570947 LL100 WITH PINNED YOKE LL100 WITH PINNED YOKE GEH COOPERSURGICAL, INC. 900019-70 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown